Director, Statistical Programming
$230,000–$245,000 year
On-site · Cambridge, Massachusetts, United States
Cambridge, Massachusetts, United StatesOn-siteFull Time$230,000–$245,000 yearSenior LevelDoctorate Or Professional DegreeBiotechUnknown
Type
Full Time
Level
Senior Level
Education
Doctorate Or Professional Degree
Company size
Unknown
Industry
Biotech
Job Summary
Director, Statistical Programming leads and oversees programming activities across clinical studies, ensuring CDISC-compliant datasets (SDTM, ADaM) and TFLs are developed and validated; collaborates with biostatisticians and cross-functional teams, oversees CROs, ensures regulatory-compliant outputs, and conducts independent validation and quality control of programming deliverables while managing multiple projects and timelines.
Required Qualifications
- PhD in Statistics/Biostatistics
- 12+ years of experience in biotech, pharma or related industries
- Hands-on programming for clinical development
- Direct experience with regulatory submissions (NDAs, BLAs, and other filings) with ISS/ISE
- Advance expertise with SAS programming and CDISC standards
- Working knowledge of ICH/GCP guidelines and global regulatory submission requirements (FDA, EMA)
- Extensive experience overseeing CROs, including independent validation of datasets and statistical deliverables
- Proficiency in SAS and/or R
- Strong communication skills and ability to translate complex concepts for various audiences
- Demonstrated entrepreneurial spirit and ability to lead fast-paced projects
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.