If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Statistical Programming Data Strategy and Governance (DSG) group is accountable for data standards, data governance, and the enablement of transformative clinical trial data initiatives within the Data Intelligence and Programming Science (DIPS) group. The Senior Principal Data Governance Lead is a Subject Matter Expert in all areas of clinical trial data governance. They are also literate in concepts of data engineering, data standards, data modelling and modern data platforms, to enable close collaboration with associated partner functions. They are accountable for DIPS' implementation of the Enterprise Data Governance framework within DIPS, acting as the Data Governance Lead and coordinating other roles in the data governance structure. Through this, they define clear ownership and stewardship of statistical programming data products, they define and enforce policies for data access, use and retention, and they establish data product fitness and quality metrics, to realize the group's data governance and data strategy goals. Where appropriate they implement tools and define processes, including data ingress/egress and data anonymization, to enable the framework and monitor compliance. They enable DIPS team members and cross-functional data consumers to realize the value of statistical programming data products and enable the broader R&D data strategy for advanced analytics, AI and automation, in compliance with the data governance framework, departmental SOPs, data privacy policies, regulatory requirements and information governance. They partner with statistical programming data owners and cross-functional data consumers to define new data use cases and incorporate these into the overall IDASP and R&D data ecosystems. Essential Functions/Responsibilities Attend department leadership and multi-disciplinary team meetings, representing the DSG function in a senior capacity. Lead the DSG strategy for data governance in their area(s) of expertise, demonstrating problem-solving and critical-thinking abilities. Implement the Enterprise Data Governance Framework within Statistical Programming. Monitor adherence to data governance policies and implementation best practices in the IDASP group through the data governance model. Train DIPS group members on domain and technical topics. Collaborate with data owners, consumers, and partner functions, on the implementation of data governance. Collaborate with partner functions on the implementation of modern data platforms for clinical trial data pipelines, warehousing and cataloguing. Provide input on data quality measures for key deliverables when requested by DIPS team members. Contribute to department SOPs and guidelines related to clinical programming. Oversee work of internal contract programmers and external vendors. Participate in vendor qualification and selection. Provide time and resource estimates for activity planning. Required Knowledge, Skills, and Abilities Minimum of 7 years of experience across a combination of clinical trial data governance and clinical statistical programming. Minimum of 3 years experience in a governance leadership and implementation role. Expert knowledge of clinical trial data privacy and information governance guidelines and best practices. Good knowledge of the drug development process and the regulatory submission process including NDAs/BLAs. Literate in concepts of data engineering, data standards, data modelling, and modern data platforms such as Snowflake. Solid verbal and written communication skills. Required/Preferred Education and Licenses Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $152,800.00 - $229,200.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
11/04/2026
Full time
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Statistical Programming Data Strategy and Governance (DSG) group is accountable for data standards, data governance, and the enablement of transformative clinical trial data initiatives within the Data Intelligence and Programming Science (DIPS) group. The Senior Principal Data Governance Lead is a Subject Matter Expert in all areas of clinical trial data governance. They are also literate in concepts of data engineering, data standards, data modelling and modern data platforms, to enable close collaboration with associated partner functions. They are accountable for DIPS' implementation of the Enterprise Data Governance framework within DIPS, acting as the Data Governance Lead and coordinating other roles in the data governance structure. Through this, they define clear ownership and stewardship of statistical programming data products, they define and enforce policies for data access, use and retention, and they establish data product fitness and quality metrics, to realize the group's data governance and data strategy goals. Where appropriate they implement tools and define processes, including data ingress/egress and data anonymization, to enable the framework and monitor compliance. They enable DIPS team members and cross-functional data consumers to realize the value of statistical programming data products and enable the broader R&D data strategy for advanced analytics, AI and automation, in compliance with the data governance framework, departmental SOPs, data privacy policies, regulatory requirements and information governance. They partner with statistical programming data owners and cross-functional data consumers to define new data use cases and incorporate these into the overall IDASP and R&D data ecosystems. Essential Functions/Responsibilities Attend department leadership and multi-disciplinary team meetings, representing the DSG function in a senior capacity. Lead the DSG strategy for data governance in their area(s) of expertise, demonstrating problem-solving and critical-thinking abilities. Implement the Enterprise Data Governance Framework within Statistical Programming. Monitor adherence to data governance policies and implementation best practices in the IDASP group through the data governance model. Train DIPS group members on domain and technical topics. Collaborate with data owners, consumers, and partner functions, on the implementation of data governance. Collaborate with partner functions on the implementation of modern data platforms for clinical trial data pipelines, warehousing and cataloguing. Provide input on data quality measures for key deliverables when requested by DIPS team members. Contribute to department SOPs and guidelines related to clinical programming. Oversee work of internal contract programmers and external vendors. Participate in vendor qualification and selection. Provide time and resource estimates for activity planning. Required Knowledge, Skills, and Abilities Minimum of 7 years of experience across a combination of clinical trial data governance and clinical statistical programming. Minimum of 3 years experience in a governance leadership and implementation role. Expert knowledge of clinical trial data privacy and information governance guidelines and best practices. Good knowledge of the drug development process and the regulatory submission process including NDAs/BLAs. Literate in concepts of data engineering, data standards, data modelling, and modern data platforms such as Snowflake. Solid verbal and written communication skills. Required/Preferred Education and Licenses Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $152,800.00 - $229,200.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Principal Statistical Programmer is a high-level technical expert and study-level programming lead within the Data Intelligence & Programming Science department. This individual is responsible for leading statistical programming activities for multiple complex clinical trials or entire compound-level programs across our Neuroscience or Oncology portfolios. The Principal Statistical Programmer provides hands-on technical and operational leadership, overseeing the creation, quality control, and delivery of CDISC-compliant datasets (SDTM and ADaM), statistical tables, figures, and listings (TFLs), integrated summaries (ISS/ISE), and electronic submission deliverables for global health authorities. Additionally, this role mentors junior and senior programmers, oversees contract research organization (CRO) deliverables, and contributes to the modernization of departmental programming standards, reusable macros, and automated workflows. Essential Functions/Responsibilities Study & Program-Level Technical Leadership Serve as the Lead Statistical Programmer across complex Phase I-IV clinical trials or multi-study project areas, taking accountability for all programming deliverables from study startup through final CSR and filing. Author, review, and finalize Statistical Analysis Plans (SAPs), dataset specifications, and TFL mock shells in close partnership with Study Biostatisticians and Clinical Scientists. Direct study-level programming timelines, resource allocations, and risk mitigation strategies to ensure timely delivery of clean data milestones, interim analyses, and final database locks. CDISC Implementation & Regulatory Submissions Architect, program, and validate CDISC-compliant SDTM and ADaM datasets, ensuring strict conformance with standard implementation guides, define.xml requirements, and therapeutic area user guides (TAUGs). Create, validate, and troubleshoot complex statistical tables, figures, and listings for Clinical Study Reports (CSRs), Safety Monitoring Committees (IDMC/DSMB), and exploratory queries using SAS, R, and modern programming packages. Lead the preparation and packaging of electronic submission datasets and documentation (Define.xml, Reviewer's Guides SDRG/ADRG , Pinnaccle 21 validation reports) in compliance with FDA, EMA, and PMDA standards. Prepare integrated summaries of safety and efficacy (ISS/ISE) to support global regulatory filings (NDA/BLA/MAA) and rapid-response inquiries. Vendor Oversight & Technical Review Provide direct technical oversight and quality assurance for programming deliverables executed by external CRO partners and functional service providers (FSPs). Review CRO-generated specifications, raw data mappings, analysis datasets, and TFLs to ensure strict alignment with Jazz standards, specifications, and regulatory guidelines. Facilitate smooth data transfer and milestone coordination between internal cross-functional teams and external programming teams. Innovation, Standards & Departmental Development Design, validate, and maintain global departmental SAS macros, R functions, automation scripts, and standardized TFL templates to enhance productivity and code reproducibility. Participate in the evaluation and piloting of new technologies, automated pipelines, or open-source statistical computing tools within a validated environment. Actively mentor and develop junior and mid-level statistical programmers, providing code reviews, best practices guidance, and technical troubleshooting support. Required Knowledge, Skills, and Abilities Mastery of Statistical Programming: Expert-level proficiency in SAS (Base, Stat, Macro, ODS, Graph) and data manipulation techniques, with proven proficiency or working knowledge of R/Python in a validated clinical environment. CDISC & Regulatory Standards: Thorough mastery of CDISC SDTM and ADaM models, Define.xml generation, and Pinnacle 21 validation tools. Regulatory Filing Experience: Demonstrated hands-on experience authoring submission-level deliverables, including ISS/ISE integration, SDRG/ADRG documentation, and direct experience supporting an NDA, BLA, or MAA submission. Analytical & Problem-Solving Capabilities: Proven ability to resolve complex programming logic challenges, design efficient data algorithms, and optimize heavy data workflows. Cross-Functional Collaboration: Exceptional communication skills with the ability to collaborate effectively with Biostatisticians, Data Managers, Medical Monitors, and Regulatory Operations. Quality & GxP Compliance: Thorough knowledge of ICH/GCP guidelines, 21 CFR Part 11, computer systems validation (CSV) principles, and standard operating procedures governing clinical reporting. Required/Preferred Education and Licenses Bachelor's, Master's, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline. Minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry (or 6+ years with an advanced degree). Proven track record of serving as the primary study or program lead programmer for multiple clinical studies across early- or late-stage development. Direct experience supporting at least one major regulatory filing (NDA, BLA, MAA) or complex integrated analysis (ISS/ISE) is strongly preferred. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $138,400.00 - $207,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
11/04/2026
Full time
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Principal Statistical Programmer is a high-level technical expert and study-level programming lead within the Data Intelligence & Programming Science department. This individual is responsible for leading statistical programming activities for multiple complex clinical trials or entire compound-level programs across our Neuroscience or Oncology portfolios. The Principal Statistical Programmer provides hands-on technical and operational leadership, overseeing the creation, quality control, and delivery of CDISC-compliant datasets (SDTM and ADaM), statistical tables, figures, and listings (TFLs), integrated summaries (ISS/ISE), and electronic submission deliverables for global health authorities. Additionally, this role mentors junior and senior programmers, oversees contract research organization (CRO) deliverables, and contributes to the modernization of departmental programming standards, reusable macros, and automated workflows. Essential Functions/Responsibilities Study & Program-Level Technical Leadership Serve as the Lead Statistical Programmer across complex Phase I-IV clinical trials or multi-study project areas, taking accountability for all programming deliverables from study startup through final CSR and filing. Author, review, and finalize Statistical Analysis Plans (SAPs), dataset specifications, and TFL mock shells in close partnership with Study Biostatisticians and Clinical Scientists. Direct study-level programming timelines, resource allocations, and risk mitigation strategies to ensure timely delivery of clean data milestones, interim analyses, and final database locks. CDISC Implementation & Regulatory Submissions Architect, program, and validate CDISC-compliant SDTM and ADaM datasets, ensuring strict conformance with standard implementation guides, define.xml requirements, and therapeutic area user guides (TAUGs). Create, validate, and troubleshoot complex statistical tables, figures, and listings for Clinical Study Reports (CSRs), Safety Monitoring Committees (IDMC/DSMB), and exploratory queries using SAS, R, and modern programming packages. Lead the preparation and packaging of electronic submission datasets and documentation (Define.xml, Reviewer's Guides SDRG/ADRG , Pinnaccle 21 validation reports) in compliance with FDA, EMA, and PMDA standards. Prepare integrated summaries of safety and efficacy (ISS/ISE) to support global regulatory filings (NDA/BLA/MAA) and rapid-response inquiries. Vendor Oversight & Technical Review Provide direct technical oversight and quality assurance for programming deliverables executed by external CRO partners and functional service providers (FSPs). Review CRO-generated specifications, raw data mappings, analysis datasets, and TFLs to ensure strict alignment with Jazz standards, specifications, and regulatory guidelines. Facilitate smooth data transfer and milestone coordination between internal cross-functional teams and external programming teams. Innovation, Standards & Departmental Development Design, validate, and maintain global departmental SAS macros, R functions, automation scripts, and standardized TFL templates to enhance productivity and code reproducibility. Participate in the evaluation and piloting of new technologies, automated pipelines, or open-source statistical computing tools within a validated environment. Actively mentor and develop junior and mid-level statistical programmers, providing code reviews, best practices guidance, and technical troubleshooting support. Required Knowledge, Skills, and Abilities Mastery of Statistical Programming: Expert-level proficiency in SAS (Base, Stat, Macro, ODS, Graph) and data manipulation techniques, with proven proficiency or working knowledge of R/Python in a validated clinical environment. CDISC & Regulatory Standards: Thorough mastery of CDISC SDTM and ADaM models, Define.xml generation, and Pinnacle 21 validation tools. Regulatory Filing Experience: Demonstrated hands-on experience authoring submission-level deliverables, including ISS/ISE integration, SDRG/ADRG documentation, and direct experience supporting an NDA, BLA, or MAA submission. Analytical & Problem-Solving Capabilities: Proven ability to resolve complex programming logic challenges, design efficient data algorithms, and optimize heavy data workflows. Cross-Functional Collaboration: Exceptional communication skills with the ability to collaborate effectively with Biostatisticians, Data Managers, Medical Monitors, and Regulatory Operations. Quality & GxP Compliance: Thorough knowledge of ICH/GCP guidelines, 21 CFR Part 11, computer systems validation (CSV) principles, and standard operating procedures governing clinical reporting. Required/Preferred Education and Licenses Bachelor's, Master's, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline. Minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry (or 6+ years with an advanced degree). Proven track record of serving as the primary study or program lead programmer for multiple clinical studies across early- or late-stage development. Direct experience supporting at least one major regulatory filing (NDA, BLA, MAA) or complex integrated analysis (ISS/ISE) is strongly preferred. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $138,400.00 - $207,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Statistical Programming Data Strategy and Governance (DSG) group is accountable for data standards, data governance, and the enablement of transformative clinical trial data initiatives within the Data Intelligence and Programming Science (DIPS) group. The Senior Principal Data Governance Lead is a Subject Matter Expert in all areas of clinical trial data governance. They are also literate in concepts of data engineering, data standards, data modelling and modern data platforms, to enable close collaboration with associated partner functions. They are accountable for DIPS' implementation of the Enterprise Data Governance framework within DIPS, acting as the Data Governance Lead and coordinating other roles in the data governance structure. Through this, they define clear ownership and stewardship of statistical programming data products, they define and enforce policies for data access, use and retention, and they establish data product fitness and quality metrics, to realize the group's data governance and data strategy goals. Where appropriate they implement tools and define processes, including data ingress/egress and data anonymization, to enable the framework and monitor compliance. They enable DIPS team members and cross-functional data consumers to realize the value of statistical programming data products and enable the broader R&D data strategy for advanced analytics, AI and automation, in compliance with the data governance framework, departmental SOPs, data privacy policies, regulatory requirements and information governance. They partner with statistical programming data owners and cross-functional data consumers to define new data use cases and incorporate these into the overall IDASP and R&D data ecosystems. Essential Functions/Responsibilities Attend department leadership and multi-disciplinary team meetings, representing the DSG function in a senior capacity. Lead the DSG strategy for data governance in their area(s) of expertise, demonstrating problem-solving and critical-thinking abilities. Implement the Enterprise Data Governance Framework within Statistical Programming. Monitor adherence to data governance policies and implementation best practices in the IDASP group through the data governance model. Train DIPS group members on domain and technical topics. Collaborate with data owners, consumers, and partner functions, on the implementation of data governance. Collaborate with partner functions on the implementation of modern data platforms for clinical trial data pipelines, warehousing and cataloguing. Provide input on data quality measures for key deliverables when requested by DIPS team members. Contribute to department SOPs and guidelines related to clinical programming. Oversee work of internal contract programmers and external vendors. Participate in vendor qualification and selection. Provide time and resource estimates for activity planning. Required Knowledge, Skills, and Abilities Minimum of 7 years of experience across a combination of clinical trial data governance and clinical statistical programming. Minimum of 3 years experience in a governance leadership and implementation role. Expert knowledge of clinical trial data privacy and information governance guidelines and best practices. Good knowledge of the drug development process and the regulatory submission process including NDAs/BLAs. Literate in concepts of data engineering, data standards, data modelling, and modern data platforms such as Snowflake. Solid verbal and written communication skills. Required/Preferred Education and Licenses Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $152,800.00 - $229,200.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
11/04/2026
Full time
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Statistical Programming Data Strategy and Governance (DSG) group is accountable for data standards, data governance, and the enablement of transformative clinical trial data initiatives within the Data Intelligence and Programming Science (DIPS) group. The Senior Principal Data Governance Lead is a Subject Matter Expert in all areas of clinical trial data governance. They are also literate in concepts of data engineering, data standards, data modelling and modern data platforms, to enable close collaboration with associated partner functions. They are accountable for DIPS' implementation of the Enterprise Data Governance framework within DIPS, acting as the Data Governance Lead and coordinating other roles in the data governance structure. Through this, they define clear ownership and stewardship of statistical programming data products, they define and enforce policies for data access, use and retention, and they establish data product fitness and quality metrics, to realize the group's data governance and data strategy goals. Where appropriate they implement tools and define processes, including data ingress/egress and data anonymization, to enable the framework and monitor compliance. They enable DIPS team members and cross-functional data consumers to realize the value of statistical programming data products and enable the broader R&D data strategy for advanced analytics, AI and automation, in compliance with the data governance framework, departmental SOPs, data privacy policies, regulatory requirements and information governance. They partner with statistical programming data owners and cross-functional data consumers to define new data use cases and incorporate these into the overall IDASP and R&D data ecosystems. Essential Functions/Responsibilities Attend department leadership and multi-disciplinary team meetings, representing the DSG function in a senior capacity. Lead the DSG strategy for data governance in their area(s) of expertise, demonstrating problem-solving and critical-thinking abilities. Implement the Enterprise Data Governance Framework within Statistical Programming. Monitor adherence to data governance policies and implementation best practices in the IDASP group through the data governance model. Train DIPS group members on domain and technical topics. Collaborate with data owners, consumers, and partner functions, on the implementation of data governance. Collaborate with partner functions on the implementation of modern data platforms for clinical trial data pipelines, warehousing and cataloguing. Provide input on data quality measures for key deliverables when requested by DIPS team members. Contribute to department SOPs and guidelines related to clinical programming. Oversee work of internal contract programmers and external vendors. Participate in vendor qualification and selection. Provide time and resource estimates for activity planning. Required Knowledge, Skills, and Abilities Minimum of 7 years of experience across a combination of clinical trial data governance and clinical statistical programming. Minimum of 3 years experience in a governance leadership and implementation role. Expert knowledge of clinical trial data privacy and information governance guidelines and best practices. Good knowledge of the drug development process and the regulatory submission process including NDAs/BLAs. Literate in concepts of data engineering, data standards, data modelling, and modern data platforms such as Snowflake. Solid verbal and written communication skills. Required/Preferred Education and Licenses Bachelor's Degree in Computer Science, Statistics, Mathematics, Life Sciences or other relevant scientific fields. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $152,800.00 - $229,200.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Principal Statistical Programmer is a high-level technical expert and study-level programming lead within the Data Intelligence & Programming Science department. This individual is responsible for leading statistical programming activities for multiple complex clinical trials or entire compound-level programs across our Neuroscience or Oncology portfolios. The Principal Statistical Programmer provides hands-on technical and operational leadership, overseeing the creation, quality control, and delivery of CDISC-compliant datasets (SDTM and ADaM), statistical tables, figures, and listings (TFLs), integrated summaries (ISS/ISE), and electronic submission deliverables for global health authorities. Additionally, this role mentors junior and senior programmers, oversees contract research organization (CRO) deliverables, and contributes to the modernization of departmental programming standards, reusable macros, and automated workflows. Essential Functions/Responsibilities Study & Program-Level Technical Leadership Serve as the Lead Statistical Programmer across complex Phase I-IV clinical trials or multi-study project areas, taking accountability for all programming deliverables from study startup through final CSR and filing. Author, review, and finalize Statistical Analysis Plans (SAPs), dataset specifications, and TFL mock shells in close partnership with Study Biostatisticians and Clinical Scientists. Direct study-level programming timelines, resource allocations, and risk mitigation strategies to ensure timely delivery of clean data milestones, interim analyses, and final database locks. CDISC Implementation & Regulatory Submissions Architect, program, and validate CDISC-compliant SDTM and ADaM datasets, ensuring strict conformance with standard implementation guides, define.xml requirements, and therapeutic area user guides (TAUGs). Create, validate, and troubleshoot complex statistical tables, figures, and listings for Clinical Study Reports (CSRs), Safety Monitoring Committees (IDMC/DSMB), and exploratory queries using SAS, R, and modern programming packages. Lead the preparation and packaging of electronic submission datasets and documentation (Define.xml, Reviewer's Guides SDRG/ADRG , Pinnaccle 21 validation reports) in compliance with FDA, EMA, and PMDA standards. Prepare integrated summaries of safety and efficacy (ISS/ISE) to support global regulatory filings (NDA/BLA/MAA) and rapid-response inquiries. Vendor Oversight & Technical Review Provide direct technical oversight and quality assurance for programming deliverables executed by external CRO partners and functional service providers (FSPs). Review CRO-generated specifications, raw data mappings, analysis datasets, and TFLs to ensure strict alignment with Jazz standards, specifications, and regulatory guidelines. Facilitate smooth data transfer and milestone coordination between internal cross-functional teams and external programming teams. Innovation, Standards & Departmental Development Design, validate, and maintain global departmental SAS macros, R functions, automation scripts, and standardized TFL templates to enhance productivity and code reproducibility. Participate in the evaluation and piloting of new technologies, automated pipelines, or open-source statistical computing tools within a validated environment. Actively mentor and develop junior and mid-level statistical programmers, providing code reviews, best practices guidance, and technical troubleshooting support. Required Knowledge, Skills, and Abilities Mastery of Statistical Programming: Expert-level proficiency in SAS (Base, Stat, Macro, ODS, Graph) and data manipulation techniques, with proven proficiency or working knowledge of R/Python in a validated clinical environment. CDISC & Regulatory Standards: Thorough mastery of CDISC SDTM and ADaM models, Define.xml generation, and Pinnacle 21 validation tools. Regulatory Filing Experience: Demonstrated hands-on experience authoring submission-level deliverables, including ISS/ISE integration, SDRG/ADRG documentation, and direct experience supporting an NDA, BLA, or MAA submission. Analytical & Problem-Solving Capabilities: Proven ability to resolve complex programming logic challenges, design efficient data algorithms, and optimize heavy data workflows. Cross-Functional Collaboration: Exceptional communication skills with the ability to collaborate effectively with Biostatisticians, Data Managers, Medical Monitors, and Regulatory Operations. Quality & GxP Compliance: Thorough knowledge of ICH/GCP guidelines, 21 CFR Part 11, computer systems validation (CSV) principles, and standard operating procedures governing clinical reporting. Required/Preferred Education and Licenses Bachelor's, Master's, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline. Minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry (or 6+ years with an advanced degree). Proven track record of serving as the primary study or program lead programmer for multiple clinical studies across early- or late-stage development. Direct experience supporting at least one major regulatory filing (NDA, BLA, MAA) or complex integrated analysis (ISS/ISE) is strongly preferred. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $138,400.00 - $207,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
11/04/2026
Full time
If you are a current Jazz employee please apply via the Internal Career site. Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit for more information. Brief Description: The Principal Statistical Programmer is a high-level technical expert and study-level programming lead within the Data Intelligence & Programming Science department. This individual is responsible for leading statistical programming activities for multiple complex clinical trials or entire compound-level programs across our Neuroscience or Oncology portfolios. The Principal Statistical Programmer provides hands-on technical and operational leadership, overseeing the creation, quality control, and delivery of CDISC-compliant datasets (SDTM and ADaM), statistical tables, figures, and listings (TFLs), integrated summaries (ISS/ISE), and electronic submission deliverables for global health authorities. Additionally, this role mentors junior and senior programmers, oversees contract research organization (CRO) deliverables, and contributes to the modernization of departmental programming standards, reusable macros, and automated workflows. Essential Functions/Responsibilities Study & Program-Level Technical Leadership Serve as the Lead Statistical Programmer across complex Phase I-IV clinical trials or multi-study project areas, taking accountability for all programming deliverables from study startup through final CSR and filing. Author, review, and finalize Statistical Analysis Plans (SAPs), dataset specifications, and TFL mock shells in close partnership with Study Biostatisticians and Clinical Scientists. Direct study-level programming timelines, resource allocations, and risk mitigation strategies to ensure timely delivery of clean data milestones, interim analyses, and final database locks. CDISC Implementation & Regulatory Submissions Architect, program, and validate CDISC-compliant SDTM and ADaM datasets, ensuring strict conformance with standard implementation guides, define.xml requirements, and therapeutic area user guides (TAUGs). Create, validate, and troubleshoot complex statistical tables, figures, and listings for Clinical Study Reports (CSRs), Safety Monitoring Committees (IDMC/DSMB), and exploratory queries using SAS, R, and modern programming packages. Lead the preparation and packaging of electronic submission datasets and documentation (Define.xml, Reviewer's Guides SDRG/ADRG , Pinnaccle 21 validation reports) in compliance with FDA, EMA, and PMDA standards. Prepare integrated summaries of safety and efficacy (ISS/ISE) to support global regulatory filings (NDA/BLA/MAA) and rapid-response inquiries. Vendor Oversight & Technical Review Provide direct technical oversight and quality assurance for programming deliverables executed by external CRO partners and functional service providers (FSPs). Review CRO-generated specifications, raw data mappings, analysis datasets, and TFLs to ensure strict alignment with Jazz standards, specifications, and regulatory guidelines. Facilitate smooth data transfer and milestone coordination between internal cross-functional teams and external programming teams. Innovation, Standards & Departmental Development Design, validate, and maintain global departmental SAS macros, R functions, automation scripts, and standardized TFL templates to enhance productivity and code reproducibility. Participate in the evaluation and piloting of new technologies, automated pipelines, or open-source statistical computing tools within a validated environment. Actively mentor and develop junior and mid-level statistical programmers, providing code reviews, best practices guidance, and technical troubleshooting support. Required Knowledge, Skills, and Abilities Mastery of Statistical Programming: Expert-level proficiency in SAS (Base, Stat, Macro, ODS, Graph) and data manipulation techniques, with proven proficiency or working knowledge of R/Python in a validated clinical environment. CDISC & Regulatory Standards: Thorough mastery of CDISC SDTM and ADaM models, Define.xml generation, and Pinnacle 21 validation tools. Regulatory Filing Experience: Demonstrated hands-on experience authoring submission-level deliverables, including ISS/ISE integration, SDRG/ADRG documentation, and direct experience supporting an NDA, BLA, or MAA submission. Analytical & Problem-Solving Capabilities: Proven ability to resolve complex programming logic challenges, design efficient data algorithms, and optimize heavy data workflows. Cross-Functional Collaboration: Exceptional communication skills with the ability to collaborate effectively with Biostatisticians, Data Managers, Medical Monitors, and Regulatory Operations. Quality & GxP Compliance: Thorough knowledge of ICH/GCP guidelines, 21 CFR Part 11, computer systems validation (CSV) principles, and standard operating procedures governing clinical reporting. Required/Preferred Education and Licenses Bachelor's, Master's, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline. Minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry (or 6+ years with an advanced degree). Proven track record of serving as the primary study or program lead programmer for multiple clinical studies across early- or late-stage development. Direct experience supporting at least one major regulatory filing (NDA, BLA, MAA) or complex integrated analysis (ISS/ISE) is strongly preferred. Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law. FOR US BASED CANDIDATES ONLY Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the full and complete base pay range is: $138,400.00 - $207,600.00 Individual compensation paid within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, and other pertinent factors. The goal is to ensure fair and competitive compensation aligned with the candidate's expertise and contributions, within the established pay framework and our Total Compensation philosophy. Internal equity considerations will also influence individual base pay decisions. This range will be reviewed on a regular basis. At Jazz, your base pay is only one part of your total compensation package. The successful candidate may also be eligible for a discretionary annual cash bonus or incentive compensation (depending on the role), in accordance with the terms of the Company's Global Cash Bonus Plan or Incentive Compensation Plan, as well as discretionary equity grants in accordance with Jazz's Long Term Equity Incentive Plan. The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, 401k retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: .
