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 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.
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.