Job Description
NO third-party applicants
Summary:
A clinical-stage biotech company in the Bay Area, focused on oncology therapeutics, is seeking a Senior Statistical Programmer to join their highly experienced team. This role replaces a senior consultant and requires strong oncology programming and regulatory submission expertise. The ideal candidate is independent, communicative, and capable of high-level decision-making.
Qualifications & Requirements:
- 15+ years of statistical programming experience; small to mid-sized sponsor company experience preferred
- Strong oncology programming expertise
- Recent regulatory submission experience
- Ability to independently develop SAS programs and specifications (SDTM, ADaM)
- Experience with data integration for clinical summaries and quality control of submission-ready components
- Skilled in creating and maintaining listings, tabulations, graphical summaries, and formal statistical estimates/tests
- Excellent understanding of CRFs, CRF specs, protocols, and related documentation
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