Senior Manager, Statistical Programming
Date posted: Jul 17, 2026 • Boston, US • Full-time
About the role
The Senior Manager, Statistical Programming is responsible for the development of statistical programming on the study level by performing hands-on programming or oversight of outsourced programming deliverables. This role ensures statistical programming processes and deliverables align with regulatory requirements and internal procedures, and interacts with study statisticians and the study team regarding statistical programming aspects.
Responsibilities
- Provide programming support for the development or QC of:
- SDTMs
- ADaM specifications
- ADaM datasets
- TLFs (Tables, Listings, and Figures)
- Manage statistical programming activities for clinical studies related to CSR, iDMC, ad-hoc analyses, and publications.
- Ensure high quality, traceability, reproducibility, and timeliness of statistical programming deliverables to meet regulatory expectations.
- Independently implement routine and non-standard analysis algorithms for assigned projects or studies.
- Collaborate with statisticians, local and CRO programmers to define and implement analysis requirements, and perform sponsor oversight regarding data and analysis.
- Deliver exemplary performance and solve complex technical problems to inspire other programmers.
- Ensure efficient collaboration with all members of the clinical study team.
- Ensure statistical programming systems, processes, and deliverables align with relevant regulatory requirements, including:
- Clinical study reporting (e.g., ICH E3)
- Electronic records handling (e.g., 21 CFR Part 11)
- Electronic submission of clinical data to agencies (e.g., e-CTD guidance and CDISC SDTM and ADaM standards)
- Ensure datasets (SDTMs and ADaMs) are CDISC compliant.
- Keep abreast of current and new statistical programming techniques and assist in their implementation.
- Guarantee that all relevant programming documents are part of the Trial Master File.
- Contribute to the establishment and maintenance of common formats and templates for key programming documentation (e.g., standard CRF pages, Tables, Figures, and Listings).
- Understand, follow, and ensure adherence to programming SOPs; maintain awareness of industry standards, regulatory requirements, and Servier SOPs.
- Help the project lead plan and track study activities and timelines.
Requirements
- Master’s degree in Statistics, Engineering, or a relevant field.
- At least 5 years of experience in statistical programming or biostatistics in the pharmaceutical/biotechnology industry; clinical development experience preferred.
- Proficient in SAS.
- Good knowledge of CDISC ADaM and SDTM.
- Strong knowledge of relevant regulatory and data submission guidelines.
- Self-directed, technically strong, and experienced in managing statistical programmers at the study level.
- Strong study management skills with the ability to organize team work, prioritize tasks, and balance concurrent responsibilities.
- Excellent time management, negotiation, and issue resolution skills.
- Ability to educate internal and external interfaces (CROs and contractors) on statistical programming processes and regulatory requirements.
- Experience with statistical programming in Neurology is desirable.
Schedule
- Some domestic and international travel required (2-3 times per year).
- On-site in Boston (recommended 2-3 days hybrid) or 100% remote with occasional travel to Boston.
Pay
The salary range for this role is $151,000 - $172,000. An employee’s pay position within the salary range will be based on 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.
Benefits
- Medical, dental, and vision insurance.
- Flexible time off (unlimited sick time and flex time; no accrual of time off).
- 401(k) retirement plan.
- Life and disability insurance.
- Recognition programs and other benefits (all subject to eligibility requirements).