Manager, Statistical Programming ( Hybrid at Boston Waltham, MA

Manager, Statistical Programming (Permanent, Hybrid)

Waltham, MA 02453

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…

Clin Choice is currently recruiting for a Manager, Statistical Programming
, Hybrid to join our client’s team in a permanent position—an exciting opportunity to lead impactful statistical strategy in a dynamic environment.

This is a Hybrid role, with a preference for candidates who can travel to the client’s location - Waltham, MA.

We are seeking an experienced and motivated Manager, Statistical Programming to lead programming activities within the Biometrics group. This role will oversee clinical programming deliverables, drive quality and compliance, support regulatory submissions, and mentor a team of programmers. The ideal candidate will have strong expertise in SAS (and/or R), deep knowledge of CDISC standards
, experience with oncology clinical trials, and excellent leadership skills.

• Lead and mentor a team of statistical programmers, fostering development and high performance.
• Oversee internal and vendor/CRO programming deliverables, ensuring timelines and quality expectations are met.
• Establish and maintain programming standards, documentation, and best practices.
• Support planning, resourcing, and prioritization for programming activities across multiple studies.

• Oversee development and validation of SDTM and ADaM datasets according to CDISC standards and oncology study requirements.
• Supervise creation of Tables, Listings, and Figures (TLFs) for clinical study reporting and regulatory submissions.
• Ensure all deliverables are of high quality, reproducible, and aligned with regulatory expectations (e.g., FDA, EMA).
• Support automation and efficiency initiatives using SAS and/or R.
• Perform and review QC checks, resolving programming and data issues.

• Partner closely with Biostatistics, Clinical Data Management, Medical Writing, and Regulatory teams.
• Participate in study team meetings, contributing programming perspective to clinical and data discussions.
• Support preparation of submission‑ready deliverables, including reviewer guides, traceability documents, and regulatory artifacts.

• Bachelor’s or Master’s degree in Statistics, Mathematics, Computer Science, Life Sciences, or related field.
• 9–11+ years of statistical programming experience in the pharmaceutical/biotech/CRO environment.
• Strong proficiency in SAS programming; experience with R is a plus.
• Expert understanding of CDISC standards (SDTM, ADaM).
• Experience managing or mentoring programming teams.
• Demonstrated experience supporting regulatory submissions.
• Excellent communication skills and ability to work collaboratively across functions.

Once you have submitted your CV, you will receive an acknowledgement that we received it. If you meet the requirements, you will be invited for a phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.

Clin Choice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.