Job Title: Senior Manager, Statistical Programming

Work Location: Hybrid-1x a week onsite: Middlesex County, Massachusetts

Summary:

The Senior Manager, Statistical Programming will lead and support statistical programming activities for clinical studies and regulatory submissions, ensuring high-quality deliverables and effective cross-functional collaboration within a growing biometrics team.

Responsibilities:

• Lead statistical programming activities for clinical studies, including the generation and validation of analysis datasets, tables, listings, and figures for study reports and regulatory submissions.
• Oversee and manage external partners to ensure timely and accurate delivery of SDTM, ADaM datasets, and TFLs, providing expert review and validation.
• Collaborate with cross-functional teams such as Biostatistics, Data Management, Clinical Operations, Clinical Development, and Regulatory to support clinical trial objectives.
• Manage the creation and maintenance of CDISC SDTM and ADaM datasets, analysis metadata, and Define.xml for electronic submissions.
• Utilize advanced SAS programming (Base, Macros, STAT, Graph, SQL, ODS) and R/R-Shiny to support data summary, statistical analysis, and reporting activities.
• Review and provide feedback on statistical analysis plans, data management plans, case report forms, annotated CRFs, and table shells produced by external partners.
• Develop and enhance programming infrastructure and processes to improve efficiency and quality of data deliverables.
• Mentor and build a team of statistical programmers to support ongoing and future clinical trials and pipeline projects.

Qualifications:

• MS or higher in Statistics, Mathematics, or a related scientific discipline.
• At least 7 years of statistical programming experience in the pharmaceutical or biotechnology industry, with sponsor-side experience required.
• Advanced proficiency in SAS programming, including Base SAS, SAS Macros, SAS/STAT, SAS/Graph, and SAS/SQL.
• Extensive knowledge of CDISC standards, including SDTM, ADaM, and controlled terminologies.
• Experience with NDA or BLA regulatory submissions.
• Demonstrated experience managing CROs and data vendors.
• Strong understanding of ICH guidelines, GCP, and regulatory authority guidance (FDA/EMA).
• Excellent organizational, communication, and interpersonal skills.
• Experience with R and R-Shiny is a plus.
• Demonstrated career stability and growth within previous organizations.
• Preference for candidates with local experience in Greater Boston and the ability to work on a hybrid schedule (1x/week onsite preferred).
• Permanent, sponsor-side professionals only; no FSP, contractor, or consultant backgrounds.

Published Category: Data Management & Programming