Senior SAS Programmer required We are currently working with a reputable innovative Global Pharmaceutical company who are now looking for a Senior Statistical Programmer (SAS). This exciting opportunity will be responsible and accountable for the programming aspects of all clinical studies or project(s) conducted, and responsible for effective communication within the corporation and, where appropriate, with external organisations of the issues and actions related to the successful completion of programming activities within the project(s). ü Hybrid working from Central London - 3 days per week ü Competitive salary with bonus and benefits ü Commuting costs will be reimbursed Key Accountabilities; Keep in accordance with the Quality Management System, working practices, Good Clinical Practice, and ICH, ensuring that training in these areas is always kept up to date. To ensure that all programming responsibilities follow Good Programming Practice (GPP). Responsible and accountable for all programming aspects of a clinical study and where appropriate the development project(s). Primary UK contact for all programming activities of the study or project(s). Primary contact for external consultants and Service Providers (SPs) for all appropriate programming activities of the study/project(s). Contributing to and be accountable for the setting up, implementation and reporting of clinical study(s) within all appropriate programming aspects of the study(s) as the programming lead for the study/project(s). Acting as an advisor to the UK clinical/research scientists engaged in the scientific aspects of the clinical development study/project(s) and providing programming support to UK clinical scientists engaged in the study/project(s). Contributing to the development and maintenance of policies, SOPs and UK documents. Ensuring learning and knowledge transfer during and at the completion of the project. Continue to update knowledge and keep abreast of changes within the field of Programming in Clinical Development Experience required; Relevant, in depth and demonstrated experience within the pharmaceutical, contract research organisation (CRO), biotechnology or medical sector, including programming of SDTMs, ADaMs, macro creation, Tables, figures and listings development and reporting. Demonstrated proficiency with ICH/GCP guidelines, related programming guidelines (GPP) and knowledge of other regulatory guidelines relating to statistics. Flexibility and the ability to manage multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. Ability to oversee and manage CROs conducting programming aspects of clinical trials and to ensure high quality deliverables are received. Able to interact effectively at all levels within the organisation, as well as with external partners and clients. Minimum BSc in Mathematics, Statistics, or Computing or related discipline, or equivalent combination of education and experience. If this roles sounds of interest please apply direct, send your CV to or call for a further conversation
Mar 15, 2024
Full time
Senior SAS Programmer required We are currently working with a reputable innovative Global Pharmaceutical company who are now looking for a Senior Statistical Programmer (SAS). This exciting opportunity will be responsible and accountable for the programming aspects of all clinical studies or project(s) conducted, and responsible for effective communication within the corporation and, where appropriate, with external organisations of the issues and actions related to the successful completion of programming activities within the project(s). ü Hybrid working from Central London - 3 days per week ü Competitive salary with bonus and benefits ü Commuting costs will be reimbursed Key Accountabilities; Keep in accordance with the Quality Management System, working practices, Good Clinical Practice, and ICH, ensuring that training in these areas is always kept up to date. To ensure that all programming responsibilities follow Good Programming Practice (GPP). Responsible and accountable for all programming aspects of a clinical study and where appropriate the development project(s). Primary UK contact for all programming activities of the study or project(s). Primary contact for external consultants and Service Providers (SPs) for all appropriate programming activities of the study/project(s). Contributing to and be accountable for the setting up, implementation and reporting of clinical study(s) within all appropriate programming aspects of the study(s) as the programming lead for the study/project(s). Acting as an advisor to the UK clinical/research scientists engaged in the scientific aspects of the clinical development study/project(s) and providing programming support to UK clinical scientists engaged in the study/project(s). Contributing to the development and maintenance of policies, SOPs and UK documents. Ensuring learning and knowledge transfer during and at the completion of the project. Continue to update knowledge and keep abreast of changes within the field of Programming in Clinical Development Experience required; Relevant, in depth and demonstrated experience within the pharmaceutical, contract research organisation (CRO), biotechnology or medical sector, including programming of SDTMs, ADaMs, macro creation, Tables, figures and listings development and reporting. Demonstrated proficiency with ICH/GCP guidelines, related programming guidelines (GPP) and knowledge of other regulatory guidelines relating to statistics. Flexibility and the ability to manage multiple tasks to meet deadlines while delivering high quality work in a dynamic environment. Ability to oversee and manage CROs conducting programming aspects of clinical trials and to ensure high quality deliverables are received. Able to interact effectively at all levels within the organisation, as well as with external partners and clients. Minimum BSc in Mathematics, Statistics, or Computing or related discipline, or equivalent combination of education and experience. If this roles sounds of interest please apply direct, send your CV to or call for a further conversation
Senior Statistical Programmer Cambridge based Highly competitive salary and attractive benefits package We are currently working with an Industry Leader in Oncology and are looking for a Senior Statistical Programmer to join their research and development team. This is truly a fantastic role that will give you the opportunity to make an impact at work and contribute to patient health. This is a varied role that will provide statistical programming support to assist in the development and improvement of products including laboratory and clinical trials. Key Accountabilities; Providing programming support to clinical studies and R&D product development, Supporting, developing and validating software using the System Life Cycle (SLC) Establishing systems for data access, reporting and analysis. Support the development of other junior programmers in the team. Experience required: Ability to demonstrate knowledge of statistical techniques is preferable BSc (or equivalent) in Mathematics, Statistics or Computing Strong collaborating skills, able to work cross functionally with the wider department Experience in SAS Programming Organised with excellent attention to detail If this roles sounds of interest please apply direct, send your CV to or call for a further conversation
Mar 15, 2024
Full time
Senior Statistical Programmer Cambridge based Highly competitive salary and attractive benefits package We are currently working with an Industry Leader in Oncology and are looking for a Senior Statistical Programmer to join their research and development team. This is truly a fantastic role that will give you the opportunity to make an impact at work and contribute to patient health. This is a varied role that will provide statistical programming support to assist in the development and improvement of products including laboratory and clinical trials. Key Accountabilities; Providing programming support to clinical studies and R&D product development, Supporting, developing and validating software using the System Life Cycle (SLC) Establishing systems for data access, reporting and analysis. Support the development of other junior programmers in the team. Experience required: Ability to demonstrate knowledge of statistical techniques is preferable BSc (or equivalent) in Mathematics, Statistics or Computing Strong collaborating skills, able to work cross functionally with the wider department Experience in SAS Programming Organised with excellent attention to detail If this roles sounds of interest please apply direct, send your CV to or call for a further conversation
Clinical Programmer - 100% remote - 6 months rolling - Market rate Exalto Consulting are recruiting for a contract Clinical Programmer for a client who are offering 100% remote contract, outside IR35 paying market rate. Overview: This role focuses on building, customizing, and maintaining the Electronic Data Capture (EDC) systems. The Clinical Programmer ensures that the EDC platform meets the specifications of clinical trials, enabling effective data collection, validation, and reporting. The Clinical Programmer plays a pivotal role in translating data management plans into actionable EDC solutions. The ideal candidate will combine technical proficiency with an appreciation of clinical trial data management processes. Experience: Prior hands-on experience with EDC platforms, with a preference for Medidata Rave EDC or Veeva Vault. Robust technical capabilities in programming and system architecture, including Rave Architect. A comprehensive understanding of the intricacies of clinical trial processes and data management standards. Exceptional problem-solving acumen. Proven ability to collaborate with cross-functional teams, including non-technical stakeholders. Demonstrated capacity to juggle numerous projects and tasks concurrently. A history of successfully adhering to strict deadlines. Preferred Skills/Nice to have: Broad experience in clinical or statistical programming languages, including one or more of JavaScript, SQL, SAS, C#, R, VB, or Python. Experience with or a keen interest in Business Intelligence tools such as PowerBI. A foundational understanding or exposure to CDISC, STDM, ADaM standards. Self-motivated to stay up to date on the latest in EDC systems and clinical programming. If you have the above experience please send your CV for immediate consideration as our client are looking to hire ASAP
Mar 15, 2024
Contractor
Clinical Programmer - 100% remote - 6 months rolling - Market rate Exalto Consulting are recruiting for a contract Clinical Programmer for a client who are offering 100% remote contract, outside IR35 paying market rate. Overview: This role focuses on building, customizing, and maintaining the Electronic Data Capture (EDC) systems. The Clinical Programmer ensures that the EDC platform meets the specifications of clinical trials, enabling effective data collection, validation, and reporting. The Clinical Programmer plays a pivotal role in translating data management plans into actionable EDC solutions. The ideal candidate will combine technical proficiency with an appreciation of clinical trial data management processes. Experience: Prior hands-on experience with EDC platforms, with a preference for Medidata Rave EDC or Veeva Vault. Robust technical capabilities in programming and system architecture, including Rave Architect. A comprehensive understanding of the intricacies of clinical trial processes and data management standards. Exceptional problem-solving acumen. Proven ability to collaborate with cross-functional teams, including non-technical stakeholders. Demonstrated capacity to juggle numerous projects and tasks concurrently. A history of successfully adhering to strict deadlines. Preferred Skills/Nice to have: Broad experience in clinical or statistical programming languages, including one or more of JavaScript, SQL, SAS, C#, R, VB, or Python. Experience with or a keen interest in Business Intelligence tools such as PowerBI. A foundational understanding or exposure to CDISC, STDM, ADaM standards. Self-motivated to stay up to date on the latest in EDC systems and clinical programming. If you have the above experience please send your CV for immediate consideration as our client are looking to hire ASAP
Senior Statistical Programmer - Oncology Location: Cambridge or Macclesfield, UK Competitive salary and benefits Senior Statistical Programmer, Oncology Do you have passion for Programming? Do you consider yourself an SME? Would you like to apply your skills to impact drug development process and regulatory interactions in a company that follows the science and turns ideas into life-enhancing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-centric biopharmaceutical company passionate about the discovery, development, and commercialization of prescription medicines. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules in all stages of our innovative pipeline, we keep pushing forward to conquer cancer through data, innovation and evidence-based decisions. Role You will be working in the Oncology Biometrics Programming department providing statistical programming support and/or leading activities related to the analysis and reporting process at project/study level for the delivery of the statistical programming aspects of clinical development. The scope of work includes, but is not limited to, clinical study report development, regulatory submissions, commercialization, and the scientific utilization of our data for AstraZeneca products. There are many career options that you can pursue for your development and progression. Crucial for the role To succeed in this role, you need to be a hardworking individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You should have the ability to multitask, collaborate as part of a team that operates globally and have an appetite for solving problems. Bachelor's or Master's (or local equivalent) degree in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field Ability to pay attention to detail and lead/work on concurrent studies and activities Excellent verbal and written communication skills and ability to influence team members Extensive SAS programming expertise to a high level within clinical drug development Ability to work independently on the assigned programming tasks Extensive knowledge of technical and regulatory requirements Good knowledge of CDISC standards and industry processes Experience leading studies or activities in clinical trials Next Steps - Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be an excellent fit, please share this posting with them. Where can I find out more? LinkedIn Facebook Instagram Biometrics dedicated webpage
Sep 23, 2022
Full time
Senior Statistical Programmer - Oncology Location: Cambridge or Macclesfield, UK Competitive salary and benefits Senior Statistical Programmer, Oncology Do you have passion for Programming? Do you consider yourself an SME? Would you like to apply your skills to impact drug development process and regulatory interactions in a company that follows the science and turns ideas into life-enhancing medicines? Then AstraZeneca might be the one for you! AstraZeneca is a global, science-led, patient-centric biopharmaceutical company passionate about the discovery, development, and commercialization of prescription medicines. Join the team dedicated to Oncology, with an ambition to eliminate cancer as a cause of death. With multiple indications and high-quality molecules in all stages of our innovative pipeline, we keep pushing forward to conquer cancer through data, innovation and evidence-based decisions. Role You will be working in the Oncology Biometrics Programming department providing statistical programming support and/or leading activities related to the analysis and reporting process at project/study level for the delivery of the statistical programming aspects of clinical development. The scope of work includes, but is not limited to, clinical study report development, regulatory submissions, commercialization, and the scientific utilization of our data for AstraZeneca products. There are many career options that you can pursue for your development and progression. Crucial for the role To succeed in this role, you need to be a hardworking individual with an understanding of technical and regulatory requirements related to programming within the pharmaceutical or healthcare industry. You should have the ability to multitask, collaborate as part of a team that operates globally and have an appetite for solving problems. Bachelor's or Master's (or local equivalent) degree in Mathematics, Statistics, Computer Science, Life or Social Sciences or related field Ability to pay attention to detail and lead/work on concurrent studies and activities Excellent verbal and written communication skills and ability to influence team members Extensive SAS programming expertise to a high level within clinical drug development Ability to work independently on the assigned programming tasks Extensive knowledge of technical and regulatory requirements Good knowledge of CDISC standards and industry processes Experience leading studies or activities in clinical trials Next Steps - Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be an excellent fit, please share this posting with them. Where can I find out more? LinkedIn Facebook Instagram Biometrics dedicated webpage
Senior / Principal Statistical Programmer Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required What we're looking for • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Sep 22, 2022
Full time
Senior / Principal Statistical Programmer Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of. As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors. Why Syneos Health • means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference. • We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job responsibilities • Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. • Works to ensure that outputs meet quality standards and project requirements. • Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. • Keeps project team members informed of programming progress and issues requiring their attention. • Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). • Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. • Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. • Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. • Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. • Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. • Accountable for on-time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. • Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. • Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. • Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. • Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. • Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. • Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. • Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. • When serving as a technical subject matter expert for CDISC and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDISC Standards • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML) • When serving as a subject matter expert for CDISC and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. • Transfers deliverables. • Performs other work-related duties as assigned. • Minimal travel may be required What we're looking for • Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. • Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. • Knowledge and experience in the use of CDISC Standards for regulatory agency requirements. Experience in submissions to a regulatory agency preferred. • Experience in mentoring others in clinical trial process and CDISC Standards. • Excellent written and verbal communication skills. • Ability to read, write, speak and understand English. Get to know Syneos Health We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health. Additional Information: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
JOB SUMMARY This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements JOB RESPONSIBILITIES Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. Assists with the transfer of deliverables. Performs other work-related duties as assigned. Minimal travel may be required. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. QUALIFICATION REQUIREMENTS Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. Knowledge and experience in the use of SDTM guidelines to build datasets. Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
Sep 22, 2022
Full time
JOB SUMMARY This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements JOB RESPONSIBILITIES Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. Works to ensure that outputs meet quality standards and project requirements. Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. Keeps project team members informed of programming progress and issues requiring their attention. Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. Assists with the transfer of deliverables. Performs other work-related duties as assigned. Minimal travel may be required. Disclaimer: Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. QUALIFICATION REQUIREMENTS Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. Knowledge and experience in the use of SDTM guidelines to build datasets. Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. Excellent written and verbal communication skills. Ability to read, write, speak, and understand English. "Syneos Health is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Syneos Health is willing to provide reasonable accommodations required for a medical condition or disability."
Job Description The Global Life Science Hub has recently partnered with an extremely niche mid-size specialist Data Focused Organisation that provides support internationally in over 100 countries. After massive success in 2021, they re now classified as one of the hottest mid-sized CROs in the industry currently. This organisation is looking to expand its Programming team this year, leaving a massive opportunity for progression and career development. Depending on preference, we can offer positions directly working for one sponsor on FSP or multi-sponsor and can be very flexible on the position/title we offer due to having several open positions across Europe & the USA. Responsibilities: Leading projects and handling budgets Liaising with the sponsors Attending external meetings on behalf of the programming department Improving current methods, processes, and SOPs Project management Developing analysis dataset specifications Developing, maintaining, and validating SAS programs for the production and analysis of datasets and tables, figures and listings for inclusion in clinical study reports Creating new shells for TFLs Experience/Qualifications Strong knowledge of CDISC (SDTM/ADaM) Minimum of 5 years experience as a SAS programmer (CRO/Pharma companies) Budgeting and resourcing skills Leadership and mentoring skills Commercial awareness Project Management experience Apply: The Global Life Science Hub is a niche Life Science headhunting firm. We place professionals across Europe and the US for various Biotechnology, Pharmaceutical, and CRO companies ranging from small start-ups to large global organisations. If you re interested, please apply below. If this position doesn t interest you, please visit our website for a list of more vacancies - or reach out to us via: Christopher Antoniou GLS Hub
Sep 22, 2022
Full time
Job Description The Global Life Science Hub has recently partnered with an extremely niche mid-size specialist Data Focused Organisation that provides support internationally in over 100 countries. After massive success in 2021, they re now classified as one of the hottest mid-sized CROs in the industry currently. This organisation is looking to expand its Programming team this year, leaving a massive opportunity for progression and career development. Depending on preference, we can offer positions directly working for one sponsor on FSP or multi-sponsor and can be very flexible on the position/title we offer due to having several open positions across Europe & the USA. Responsibilities: Leading projects and handling budgets Liaising with the sponsors Attending external meetings on behalf of the programming department Improving current methods, processes, and SOPs Project management Developing analysis dataset specifications Developing, maintaining, and validating SAS programs for the production and analysis of datasets and tables, figures and listings for inclusion in clinical study reports Creating new shells for TFLs Experience/Qualifications Strong knowledge of CDISC (SDTM/ADaM) Minimum of 5 years experience as a SAS programmer (CRO/Pharma companies) Budgeting and resourcing skills Leadership and mentoring skills Commercial awareness Project Management experience Apply: The Global Life Science Hub is a niche Life Science headhunting firm. We place professionals across Europe and the US for various Biotechnology, Pharmaceutical, and CRO companies ranging from small start-ups to large global organisations. If you re interested, please apply below. If this position doesn t interest you, please visit our website for a list of more vacancies - or reach out to us via: Christopher Antoniou GLS Hub
* JOB SUMMARY * Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. F irst level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations. * * * JOB RESPONSIBILITIES * * Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. * Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. * Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. * Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports * Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. * Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. * Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. * Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. * Performs system integration activities, application updates, and user acceptance testing. * Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. * Assists in project meetings and actively contributes and participates in departmental review meetings. * Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. * Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. * Manages project resources, proactively alerting management of delivery and resourcing needs. * Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. *QUALIFICATION REQUIREMENTS * * Bachelor's degree preferred, or equivalent combination of related education and experience. * The ability to deal effectively with sponsors and internal customers at all levels. * Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. * Demonstrated experience in managing multiple priorities in a highly dynamic environment * Experience working in a matrix-structured environment is preferred * Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail * Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. * Ability to travel as necessary (up to 25%) This job excludes Colorado applicants. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Sep 14, 2021
Full time
* JOB SUMMARY * Serves as lead Clinical Programmer to manage and support project deliverables and timelines. Designs, writes, validates and maintains software to meet specifications. Specifies, develops and validates applications supporting data capture and processing. F irst level technical Subject Matter Expert (SME), supports the production-line clinical programming and data management staff in a support desk role for Electronic Data Capture (EDC), reporting, and processing tools. Assists in monitoring internally and externally hosted applications for performance and/or system errors. Assists support team with customers as needed to support projects and applications externally. Assists with management of external application vendor issues, integrations and implementations. * * * JOB RESPONSIBILITIES * * Utilizes primary development tools including Medidata, Rave, Oracle OC/RDC, Oracle Inform, and/or SAS, and other supporting tools to design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. * Generates and maintains all required documentation, including the development of specifications, programs, and validation efforts in support of annotated Case Report Forms (CRFs), database creation, coding configuration, edit check procedures, import setup and processing, export setup and processing, listings, and custom reports.. * Serves on project teams to coordinate and lead development activities for clinical programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive feedback. Keeps those responsible for project management informed of any issues that might impact project target dates, scope, or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources. * Provides technology support to the clinical programming staff, Project Analysts, Data Managers, etc., who design, write, validate, and maintain software to meet specifications in a timely and productive manner following standard development procedures. This includes support of the development of specifications, coding, and validation efforts in support of annotated CRFs, database creation, coding setup, edit-check procedures, import setup and processing, export setup and processing, listings, and custom reports * Provides application administration and technical support as the subject matter expert on core business packages including but not limited to: Oracle Inform, MDSOL Rave, Oracle RDC, -, SAS, and supplemental packages such as migration mentor/review, reporting tools, custom functions. * Ensures high quality deliverables by providing senior review of study level/program level/multi study core deliveries for accuracy. Attends sponsor audits and assists with in-progress audits. * Reviews and provide input on study budgets and monitors scope of work to actual work, alerting management of potential change orders; manages and executes the change order to completion. Provides input and supporting details for change orders. * Monitors applications for workflow alerts, system errors, and performance issues. Provides second tier help desk support, as needed. * Performs system integration activities, application updates, and user acceptance testing. * Provides leadership, training, guidance, and support to other department members based upon expertise in specific skill sets. Collaborates with clients, peers, lead programmers, project teams, and/or requestors to clarify and finalize specifications; uses expanded technical skills to meet evolving project needs. * Assists in project meetings and actively contributes and participates in departmental review meetings. * Attends Quick Start Camps (QSCs) as the lead Clinical Programmer role for assigned studies. * Leads clinical programming activities on three (3) to ten (10) concurrent studies depending upon scope, similarity, program, and resourcing requirements. * Manages project resources, proactively alerting management of delivery and resourcing needs. * Possesses and maintains a broad overall knowledge in the field of clinical programming and clinical data management by reading related literature, self-training, attending training classes, attending professional meetings, etc. *QUALIFICATION REQUIREMENTS * * Bachelor's degree preferred, or equivalent combination of related education and experience. * The ability to deal effectively with sponsors and internal customers at all levels. * Excellent communication and interpersonal skills, both written and spoken, with an ability to inform. * Demonstrated experience in managing multiple priorities in a highly dynamic environment * Experience working in a matrix-structured environment is preferred * Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and Voicemail * Experience with programming languages, such as PL/SQL, SAS, C#, or VB preferred. * Ability to travel as necessary (up to 25%) This job excludes Colorado applicants. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team serving as a lead statistical programmer or reviewer for any project, especially those of high complexity and scope, or integrated summaries of safety/efficacy for submission, in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project or across a program or submission; manages project budgets and tracks project specific performance metrics; functions as an internal and external customer liaison; provides input to statistical analysis plans; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets . A Principal Statistical programmer demonstrating a high degree of expertise of CDSIC (SDTM) and other industry standards / tool and regulatory requirements may serves as a subject matter experts leading innovations and providing guidance to the Biostatistics Department. * JOB RESPONSIBILITIES * * Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Accountable for on- time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. * Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. * Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. * When serving as a technical subject matter expert for CDSIC(SDTM) and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDSIC(SDTM) Standards * When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML). * When serving as a subject matter expert for CDSIC (SDTM) and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Experience in submissions to a regulatory agency preferred. * Experience in mentoring others in clinical trial process and CDSIC (SDTM) Standards. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
Sep 14, 2021
Full time
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team serving as a lead statistical programmer or reviewer for any project, especially those of high complexity and scope, or integrated summaries of safety/efficacy for submission, in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project or across a program or submission; manages project budgets and tracks project specific performance metrics; functions as an internal and external customer liaison; provides input to statistical analysis plans; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets . A Principal Statistical programmer demonstrating a high degree of expertise of CDSIC (SDTM) and other industry standards / tool and regulatory requirements may serves as a subject matter experts leading innovations and providing guidance to the Biostatistics Department. * JOB RESPONSIBILITIES * * Uses SAS, or other software, to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other programmers, biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical or sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Accountable for on- time delivery across concurrent programming deliverables. Negotiates programming timelines and provides risk mitigation plans for projects or programs, as needed. Proactively informs management of the status of deliverables and significant project or program issues, including planned resolutions. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Maintains a good working knowledge of clinical drug development, industry standards, and electronic submission requirements; serves as a technical expert resource to other department members for complex programming questions. * Works cooperatively with other biostatistics and statistical programming personnel to establish standard operation procedures (SOPs), guidelines, policies, and/or procedures. * Contributes technical expertise to the development of programming tools and macros for standardization and efficiency. * When serving as a technical subject matter expert for CDSIC(SDTM) and other industry and regulatory requirements, provides guidance and training to the Biostatistics group and other departments on the appropriate use of CDSIC(SDTM) Standards * When serving as a subject matter expert for CDISC and other industry and regulatory requirements, performs compliance reviews of project deliverables for CDISC deliverables including SDTM and ADaM specifications and datasets as well as any regulatory required documents. (i.e. DEFINE.XML). * When serving as a subject matter expert for CDSIC (SDTM) and other industry and regulatory requirements, actively participates in industry standards organizations and provides regular updates to the Biometrics Department on upcoming changes to those standards. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment as demonstrated by the ability to lead multiple complex and/or global projects with teams of statistical programmers. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Experience in submissions to a regulatory agency preferred. * Experience in mentoring others in clinical trial process and CDSIC (SDTM) Standards. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
*JOB SUMMARY* This position functions as a member of the Biostatistics and Statistical Programming project team serving as a Lead Statistical Programmer for projects of any complexity in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project; assists in managing project budgets and tracking project specific performance metrics; functions as an internal and external customer liaison; provides input to the statistical analysis plan; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets. Demonstrating knowledge of CDSIC (SDTM) and other industry standards / tool and regulatory requirements. *JOB RESPONSIBILITIES* * Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
Sep 14, 2021
Full time
*JOB SUMMARY* This position functions as a member of the Biostatistics and Statistical Programming project team serving as a Lead Statistical Programmer for projects of any complexity in the development of programs to support the conduct, statistical analysis and reporting of projects; creates, tests, and maintains programs for clinical studies, coordinating the efforts of other programming personnel; determines the overall strategy for the programming tasks on a project; assists in managing project budgets and tracking project specific performance metrics; functions as an internal and external customer liaison; provides input to the statistical analysis plan; leads the creation and maintenance of statistical programming project documentation and regulatory submission packages utilizing SDTM guidelines to build datasets. Demonstrating knowledge of CDSIC (SDTM) and other industry standards / tool and regulatory requirements. *JOB RESPONSIBILITIES* * Uses SAS or other software to develop custom programming code to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follow applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, testing, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects at a time, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * Develops specifications for datasets and outputs of any complexity according to statistical and sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming and accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Conducts effective internal meetings (appropriate in format, frequency and attendance). Distributes relevant information in advance. Ensures minutes are promptly and accurately distributed. Follows action items through to completion, and maintains order and focus of meetings, working toward consensus. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Negotiates and establishes accurate time estimates for completion of study programming activities with internal team members and statistical programming management, and completes project programming activities within timeframe allotted. * Acts as the lead statistical programmer. Directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Reviews project documentation such as Statistical Analysis Plan, mock shells, programming specifications, annotated CRFs, and SAS database design. Provides feedback to the appropriate project team members which reflects forethought and reduces inefficiencies in programming activities. * Review protocols, CRFs, annotated CRFs, test databases and Statistical Analysis Plans Develop, test and produce CDISC SDTM/ADAM datasets, derived datasets. Validate them primarily using SAS software, derived datasets, tables, listings and graphs for clinical study reports. * Supporting project teams in creating SDTM deliverables. * Participates in sponsor meetings, kickoff meetings, and bid defense meetings as statistical programming representative, as required by sponsor. * Contributes to the mentoring of programming personnel through developing training courses, presenting training materials, reviewing work, and providing feedback or guiding new associates in process. * Transfers deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate degree, preferably in a scientific or statistical discipline; in lieu of degree, an equivalent combination of education and demonstrated programming experience. * Extensive programming experience in SAS or other required software, preferably in a clinical trial environment. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Excellent written and verbal communication skills. * Ability to read, write, speak and understand English.
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements * JOB RESPONSIBILITIES * * Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. * May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Assists with the transfer of deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. * Excellent written and verbal communication skills. * Ability to read, write, speak, and understand English.
Sep 14, 2021
Full time
* JOB SUMMARY * This position functions as a member of the Biostatistics and Statistical Programming project team supporting the Lead Statistical Programmer in the development of programs to support the conduct, statistical analysis and reporting of projects. A Statistical SDTM Programmer II may serve as Lead Statistical SDTM Programmer. He or she creates, tests, and maintains programs for clinical studies, under the direction of more senior programmers. He or she participates in the creation and maintenance of Statistical Programming project documentation. De monstrating knowledge of CDSIC (SDTM) and other industry standards / tools and regulatory requirements * JOB RESPONSIBILITIES * * Uses SAS or other software to generate summary tables, data listings, graphs and derived datasets as specified in the statistical analysis plan and programming specifications. * Works to ensure that outputs meet quality standards and project requirements. * Performs validation programming and works with other Statistical Programmers, Biostatisticians, and other project team members to resolve discrepancies or any findings. * Keeps project team members informed of programming progress and issues requiring their attention. * Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH). * Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs ensuring inspection readiness. * Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, and adapts to timeline or priority changes by reorganizing daily workload. * May develop specifications for datasets and outputs according to statistical and Sponsor requirements. Anticipates and addresses potential programming issues, reflects forethought, establishes the basis for efficient programming, accurately defines all variables to be accepted by peer review and sponsor/requestor with little rework. * Prepares in advance for internal meetings, contributes ideas, and demonstrates respect for opinions of others. * Displays willingness to work with others and assist with projects and initiatives as necessary to meet the needs of the business. * Completes project programming activities within timeframe allotted by Lead SDTM Statistical Programmer and/or management. * May act as the Lead Statistical Programmer, directs the programming activities of other programming personnel and monitors progress on programming deliverables. * Assists with the transfer of deliverables. * Performs other work-related duties as assigned. * Minimal travel may be required. *Disclaimer:* Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.*QUALIFICATION REQUIREMENTS* * Undergraduate Degree, preferably in a scientific or statistical discipline; In lieu of degree, an equivalent combination of education and demonstrated programming experience. * Knowledge and experience in the use of CDSIC (SDTM) Standards for regulatory agency requirements. * Knowledge and experience in the use of SDTM guidelines to build datasets. * Proficiency in programming in SAS or other required software, preferably in a clinical trial environment. * Excellent written and verbal communication skills. * Ability to read, write, speak, and understand English.
*Senior Programmer* *Company Overview* * Join a specialist contract research organisation (CRO) based in the UK, with multiple UK offices. They focus on delivering statistics and programming for the reporting of Phase I-IV clinical trials across a variety of therapeutic areas. A respected company, boasting contracts with some of the top 10 pharma companies globally. They offer flexible working and an industry leading training programme. *Purpose of the role * * To operate as Senior Programmer, assisting lead heads on technical tasks as line manager and supporting the business operations management team. You will have the opportunity to be hands on or off, technically, depending on your preference. You will be allocated to FSPs, tasks and teams your skills best suit so you will be able to maximise your impact on the business, using your expertise *Key Responsibilities:* * Review clinical trial documentation e.g. protocols, SAPs, CRFs, CSRs * Author and review study TFL shells and complex dataset standards * Present study updates during internal and client study team meetings * Line management and mentorship of more junior team members * Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications * Complete and review CDISC Validation tool reports * Maintain study master file and important documents to be audit ready *Must have experience:* * Relevant qualification - PhD, MSc or BSc * Proven experience within industry in a CRO, Biotech/Biopharma or a pharmaceutical company * Excellent verbal and written communication skills * Demonstrated Interpersonal/teamwork skills * Proficiency in data handling using SAS or other statistical software
Mar 22, 2021
Full time
*Senior Programmer* *Company Overview* * Join a specialist contract research organisation (CRO) based in the UK, with multiple UK offices. They focus on delivering statistics and programming for the reporting of Phase I-IV clinical trials across a variety of therapeutic areas. A respected company, boasting contracts with some of the top 10 pharma companies globally. They offer flexible working and an industry leading training programme. *Purpose of the role * * To operate as Senior Programmer, assisting lead heads on technical tasks as line manager and supporting the business operations management team. You will have the opportunity to be hands on or off, technically, depending on your preference. You will be allocated to FSPs, tasks and teams your skills best suit so you will be able to maximise your impact on the business, using your expertise *Key Responsibilities:* * Review clinical trial documentation e.g. protocols, SAPs, CRFs, CSRs * Author and review study TFL shells and complex dataset standards * Present study updates during internal and client study team meetings * Line management and mentorship of more junior team members * Program and QC routine and ad hoc datasets and TFLs (in SAS) following specifications * Complete and review CDISC Validation tool reports * Maintain study master file and important documents to be audit ready *Must have experience:* * Relevant qualification - PhD, MSc or BSc * Proven experience within industry in a CRO, Biotech/Biopharma or a pharmaceutical company * Excellent verbal and written communication skills * Demonstrated Interpersonal/teamwork skills * Proficiency in data handling using SAS or other statistical software
Clinical Research Organisations are a hot topic right now, and quite rightly so. And as a Statistical Programmer for this particular CRO, you'll be at the forefront of some seriously career-defining projects - particularly as this organisation is one of the world's leading innovators in healthcare and drug discovery. Bringing healthcare data, domain expertise, transformative technology and advanced analytics into a mixing pot of genius, they're utilising the most cutting-edge technology to deliver life-changing results. Striving for nothing short of excellence, they're embarking on an exciting new era of data science, with capabilities that extend from AI and machine learning to virtual trials - and in the process, they continue to create the most exceptional career prospects for their ambitious workforce. *The role:* With multiple opportunities across Europe for both Senior Programmer and Principal Programmers, you'll be part of a vibrant Statistical Programming directorate that has access to sector-leading technology. Joining a specialist, single sponsor team on multiple complex global studies across phases I-IV, you'll be entrusted with the most spectacular trials, developing the process methodologies and quality controls needed for various departments to meet their internal and external clients' needs. With the opportunity to provide technical expertise and leadership across the department, you'll shape and coordinate the development of integrated programming solutions, and you will deliver internal consulting expertise, formulating specifications and user needs analyses for complex project and client requirements. So we've established that the work will be interesting. But it's also worth noting that this role comes with the chance to pursue your long-term career goals. With exceptional training and development opportunities that will be tailored to your needs (including the chance to maintain up-to-date advanced knowledge of programming software and CDISC requirements), you'll have first dibs on the most interesting promotions - so there really is no saying where your career will take you next. *To make waves in this exceptional Statistical Programming team, you will:* * Have experience in statistical programming in SAS within the CRO, pharmaceutical or biotechnology sectors. * Boast a comprehensive knowledge of statistics and programming within the clinical drug development process. * Have a brilliant awareness of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language. * Be organised. You'll be leading projects at a group level, so you will know how to blow expectations out of the water, while always meeting deadlines. * Have the qualifications or experience to prove that you're up to the job. A degree in computer science would be a bonus. * Be highly analytical with an in-depth knowledge of clinical research regulatory requirements. * Be inspirational, with good communication and influencing skills. In other words, you'll be capable of managing a visionary programming team and helping them achieve their best.
Mar 22, 2021
Full time
Clinical Research Organisations are a hot topic right now, and quite rightly so. And as a Statistical Programmer for this particular CRO, you'll be at the forefront of some seriously career-defining projects - particularly as this organisation is one of the world's leading innovators in healthcare and drug discovery. Bringing healthcare data, domain expertise, transformative technology and advanced analytics into a mixing pot of genius, they're utilising the most cutting-edge technology to deliver life-changing results. Striving for nothing short of excellence, they're embarking on an exciting new era of data science, with capabilities that extend from AI and machine learning to virtual trials - and in the process, they continue to create the most exceptional career prospects for their ambitious workforce. *The role:* With multiple opportunities across Europe for both Senior Programmer and Principal Programmers, you'll be part of a vibrant Statistical Programming directorate that has access to sector-leading technology. Joining a specialist, single sponsor team on multiple complex global studies across phases I-IV, you'll be entrusted with the most spectacular trials, developing the process methodologies and quality controls needed for various departments to meet their internal and external clients' needs. With the opportunity to provide technical expertise and leadership across the department, you'll shape and coordinate the development of integrated programming solutions, and you will deliver internal consulting expertise, formulating specifications and user needs analyses for complex project and client requirements. So we've established that the work will be interesting. But it's also worth noting that this role comes with the chance to pursue your long-term career goals. With exceptional training and development opportunities that will be tailored to your needs (including the chance to maintain up-to-date advanced knowledge of programming software and CDISC requirements), you'll have first dibs on the most interesting promotions - so there really is no saying where your career will take you next. *To make waves in this exceptional Statistical Programming team, you will:* * Have experience in statistical programming in SAS within the CRO, pharmaceutical or biotechnology sectors. * Boast a comprehensive knowledge of statistics and programming within the clinical drug development process. * Have a brilliant awareness of Base SAS, SAS/STAT, SAS Graph and SAS Macro Language. * Be organised. You'll be leading projects at a group level, so you will know how to blow expectations out of the water, while always meeting deadlines. * Have the qualifications or experience to prove that you're up to the job. A degree in computer science would be a bonus. * Be highly analytical with an in-depth knowledge of clinical research regulatory requirements. * Be inspirational, with good communication and influencing skills. In other words, you'll be capable of managing a visionary programming team and helping them achieve their best.
Geoff King at RBW Consulting is recruiting for multiple, permanent Principal Statistical Programmers to join a leading pharmaceutical company as they look to grow a new team of Programmers and Statisticians in the UK focused on the Oncology therapeutic area. This position is fully home based but must be in the UK. Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and Oncology. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.
Mar 22, 2021
Full time
Geoff King at RBW Consulting is recruiting for multiple, permanent Principal Statistical Programmers to join a leading pharmaceutical company as they look to grow a new team of Programmers and Statisticians in the UK focused on the Oncology therapeutic area. This position is fully home based but must be in the UK. Principal level Statistical Programmers are required for this science-led healthcare company who have an incredibly exciting range of products in the pipeline across multiple therapeutic area's including Respiratory, Infectious Disease, Immuno-Inflammatory and Oncology. As a Statistical Programmer you will play an important part in delivering the companies mission in helping people to do more, feel better and live longer. As part of a diverse, global team you will have the opportunity to work in an environment where you realise your full potential and achieve your career goals. *Main duties & responsibilities:* * Contribute to the delivery SDTM/ADaM datasets and TFL outputs * Contribute to the statistical programming deliverables for regulatory submissions * Produce and maintain technical database standards and programming specification documents * Contribute to the development of best practice to improve quality, efficiency and effectiveness * Prepare graphs, tables and listings for inclusion in clinical study reports *Key requirements:* * BSc in Mathematics, Statistics, Computer Science or related field * SAS programming experience working within a clinical trials environment (Pharma, CRO or biotech) * Knowledge of CDSIC standards and industry best practices * Excellent written and verbal communication skills * Ability to communicate with a broad range of people across different functions A comprehensive job description is available upon request. To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Geoff King on (0) and send your CV through to [](mailto:) or use the apply button on this page. If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential.