{"schemaVersion":"jobsearcher.job.v1","id":"ee2ca7eee9eac0c2af4720fe","url":"https://jobsearcher.com/jobs/ee2ca7eee9eac0c2af4720fe","canonicalUrl":"https://jobsearcher.com/jobs/ee2ca7eee9eac0c2af4720fe","title":"Associate Director, Statistical Programming","description":"Associate Director, Statistical Programming\nAbout Servier\nServier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting‑edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.\n\nJob Description\nRole Summary\nThe Associate Director, Statistical Programming leads statistical programming activities for multiple studies, an asset or an indication by performing hands‑on programming or oversight of outsourced deliverables. This individual ensures that the statistical programming processes and deliverables are aligned with regulatory requirements and internal procedures. The role interacts closely with the study statisticians and study team regarding statistical programming aspects.\n\nPrimary Responsibilities\n\nManage statistical programming deliverables on one or more assets or indications by managing study leads and overseeing study activities and vendor oversight.\n\nOversee development and quality control or oversight plan of analysis datasets and outputs for individual study as well as integrated analyses.\n\nEnsure study leads deliver high quality, traceability, reproducibility of study outputs and timeliness of statistical programming deliverables to meet expectations and regulatory requirements.\n\nMentor statistical programmers with regards to programming activities and project management.\n\nIndependently implement routine and non‑standard analysis algorithms for assigned projects or studies.\n\nCollaborate with statisticians, local and CRO programmers to define and implement analysis requirements and perform sponsor oversight regarding data and analysis.\n\nEnsure an efficient collaboration with all members of the clinical study team.\n\nEnsure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:\n\nClinical study reporting, e.g., ICH E3\n\nElectronic records handling, e.g., Chapter 21 of the US Code of Federal Regulation – Part11\n\nElectronic submission of clinical data to agencies, e.g., e‑CTD guidance and CDISC SDTM and ADaM standards.\n\nEnsure that the datasets (SDTMs and ADaMs) are CDISC compliant.\n\nSupport on the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to achieve the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.\n\nWork with the portfolio programming lead to create forecasts for different studies and resource requirements.\n\nOther responsibilities\n\nParticipate in working groups (either inter‑department or cross‑functional).\n\nParticipate in the preparation of audit/inspection and could interact with auditors/inspectors.\n\nContribute to the establishment and maintenance of common formats and templates for key Programming documentation (e.g., standard CRF pages, Tables, Figures and Listings).\n\nPlan and track project activities, timelines across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well‑managed projects, capacity to apply extra resources in urgent situations.\n\nEducation and Required Skills\n\nMasters in Statistics, Engineering or relevant field required with a minimum of 8 years of experience in statistical programming or biostatistics in the Pharmaceutical/Biotechnology industry in clinical development desirable.\n\nExperience with statistical programming in Oncology desirable.\n\nProficient in SAS.\n\nGood knowledge of CDISC ADaM and SDTM.\n\nStrong knowledge of relevant regulatory and data submission guidelines.\n\nStrong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.\n\nSelf‑directed, technically strong, expert regarding statistical programming processes, management of statistical programmers at study level.\n\nGood negotiation and issue resolution skills.\n\nAbility to organize team work and prioritize and balance concurrent tasks and responsibilities.\n\nAbility to educate internal and external interfaces (CROs and contractors) on the statistical programming processes, and the underlying regulatory requirements.\n\nTravel and Location\n\nSome domestic and international travel required.\n\nOn‑site in Boston (recommended 2‑3 days hybrid) or 100% remote with occasional travel to Boston.\n\nServier’s Commitment\nServier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.\n\nAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.\n\nSalary Range\nThe salary range for this role is $165,000–$200,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. Employees in this position are also eligible for Short‑Term and Long‑Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes medical, dental, vision, flexible time off, 401(k), life and disability insurance, recognition programs and other great benefits (all benefits are subject to eligibility requirements).\n\n#J-18808-Ljbffr","company":"Servier Group","rawCompany":"servier group","city":"East Boston","state":"MA","isRemote":false,"isActive":false,"createdAt":"2026-07-20T03:16:26.535Z","occupations":[{"code":"15-2041.01","title":"Biostatisticians","slug":"biostatisticians"},{"code":"15-2041.00","title":"Statisticians","slug":"statisticians"},{"code":"43-9111.00","title":"Statistical Assistants","slug":"statistical-assistants"}],"industries":[{"code":"541714","title":"Research and Development in Biotechnology (except Nanobiotechnology)","slug":"research-and-development-in-biotechnology-except-nanobiotechnology"},{"code":"541690","title":"Other Scientific and Technical Consulting Services","slug":"other-scientific-and-technical-consulting-services"},{"code":"541715","title":"Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)","slug":"research-and-development-in-the-physical-engineering-and-life-sciences-except-nanotechnology-and-biotechnology"}],"jobPosting":{"@context":"https://schema.org","@type":"JobPosting","title":"Associate Director, Statistical Programming","description":"Associate Director, Statistical Programming\nAbout Servier\nServier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting‑edge science, tackle underserved therapeutic areas and make patients the focus of every strategic decision.\n\nJob Description\nRole Summary\nThe Associate Director, Statistical Programming leads statistical programming activities for multiple studies, an asset or an indication by performing hands‑on programming or oversight of outsourced deliverables. This individual ensures that the statistical programming processes and deliverables are aligned with regulatory requirements and internal procedures. The role interacts closely with the study statisticians and study team regarding statistical programming aspects.\n\nPrimary Responsibilities\n\nManage statistical programming deliverables on one or more assets or indications by managing study leads and overseeing study activities and vendor oversight.\n\nOversee development and quality control or oversight plan of analysis datasets and outputs for individual study as well as integrated analyses.\n\nEnsure study leads deliver high quality, traceability, reproducibility of study outputs and timeliness of statistical programming deliverables to meet expectations and regulatory requirements.\n\nMentor statistical programmers with regards to programming activities and project management.\n\nIndependently implement routine and non‑standard analysis algorithms for assigned projects or studies.\n\nCollaborate with statisticians, local and CRO programmers to define and implement analysis requirements and perform sponsor oversight regarding data and analysis.\n\nEnsure an efficient collaboration with all members of the clinical study team.\n\nEnsure the statistical programming systems, processes and deliverables are aligned with the relevant regulatory requirements, for instance:\n\nClinical study reporting, e.g., ICH E3\n\nElectronic records handling, e.g., Chapter 21 of the US Code of Federal Regulation – Part11\n\nElectronic submission of clinical data to agencies, e.g., e‑CTD guidance and CDISC SDTM and ADaM standards.\n\nEnsure that the datasets (SDTMs and ADaMs) are CDISC compliant.\n\nSupport on the design of new statistical programming processes or optimization of existing ones to reach the best productivity, to ensure the best quality of the statistical outputs, and to achieve the best customer satisfaction (internally and externally) with flexibility, reliability and responsiveness.\n\nWork with the portfolio programming lead to create forecasts for different studies and resource requirements.\n\nOther responsibilities\n\nParticipate in working groups (either inter‑department or cross‑functional).\n\nParticipate in the preparation of audit/inspection and could interact with auditors/inspectors.\n\nContribute to the establishment and maintenance of common formats and templates for key Programming documentation (e.g., standard CRF pages, Tables, Figures and Listings).\n\nPlan and track project activities, timelines across projects. Provide justification for planned resource needs. Seek to optimize resource utilization and capacity. Accurate plans, well‑managed projects, capacity to apply extra resources in urgent situations.\n\nEducation and Required Skills\n\nMasters in Statistics, Engineering or relevant field required with a minimum of 8 years of experience in statistical programming or biostatistics in the Pharmaceutical/Biotechnology industry in clinical development desirable.\n\nExperience with statistical programming in Oncology desirable.\n\nProficient in SAS.\n\nGood knowledge of CDISC ADaM and SDTM.\n\nStrong knowledge of relevant regulatory and data submission guidelines.\n\nStrong understanding of drug development, including knowledge of interfaces and interdependencies with other functions.\n\nSelf‑directed, technically strong, expert regarding statistical programming processes, management of statistical programmers at study level.\n\nGood negotiation and issue resolution skills.\n\nAbility to organize team work and prioritize and balance concurrent tasks and responsibilities.\n\nAbility to educate internal and external interfaces (CROs and contractors) on the statistical programming processes, and the underlying regulatory requirements.\n\nTravel and Location\n\nSome domestic and international travel required.\n\nOn‑site in Boston (recommended 2‑3 days hybrid) or 100% remote with occasional travel to Boston.\n\nServier’s Commitment\nServier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.\n\nAll qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.\n\nSalary Range\nThe salary range for this role is $165,000–$200,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. Employees in this position are also eligible for Short‑Term and Long‑Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes medical, dental, vision, flexible time off, 401(k), life and disability insurance, recognition programs and other great benefits (all benefits are subject to eligibility requirements).\n\n#J-18808-Ljbffr","datePosted":"2026-07-20T03:16:26.535Z","dateModified":"2026-07-20T03:16:26.535Z","hiringOrganization":{"@type":"Organization","name":"Servier Group","sameAs":"https://jobsearcher.com"},"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressLocality":"East Boston","addressRegion":"MA","addressCountry":"US"}},"identifier":{"@type":"PropertyValue","name":"JobSearcher","value":"ee2ca7eee9eac0c2af4720fe"},"url":"https://jobsearcher.com/jobs/ee2ca7eee9eac0c2af4720fe"}}