Director, Statistical Programming
$229,000–$279,000 year
Hybrid · South San Francisco, California, United States
Job Summary
Direct statistical programming across multiple clinical studies and regulatory submissions, defining strategy, standards, and best practices; lead design, development, validation, and maintenance of SAS macros, scripts, and applications supporting analysis, reporting, and regulatory deliverables (SDTM, ADaM, TLFs); ensure robust, regulatory-compliant programming infrastructure (FDA 21 CFR Part 11, GxP) and audit readiness; drive automation and standardization of workflows; collaborate with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define requirements and ensure data integrity; manage CROs and external programming vendors including scope, timelines, quality, and budget; support outsourcing strategy and vendor selection; demonstrate leadership competencies in communication, influence, teamwork, execution, and staff development; advanced degree with 10+ years (or Ph.D. with 8+ years) and a track record of leading programming efforts across studies/regulatory submissions; CDISC standards familiarity and submission-ready deliverables; expected salary range for SF Bay Area: $229,000-$279,000 with eligibility for annual bonus.
Required Qualifications
- An advanced degree in Statistics, Computer Science, Mathematics, or related discipline
- Master’s degree with 10+ years of experience, or Ph.D. with 8+ years of experience
- A track record of leading statistical programming efforts across multiple clinical studies or regulatory submissions
- Strong decision-making skills and the ability to guide teams through ambiguity while influencing across project teams
- A collaborative leadership style that emphasizes mentorship, knowledge sharing, and developing others
- Deep technical expertise in statistical programming for clinical research, with familiarity in CDISC standards, submission-ready deliverables, and modern programming best practices
Desired Qualifications
- Master’s degree with 10+ years of experience, or Ph.D. with 8+ years of experience
- Track record of leading statistical programming efforts across multiple clinical studies or regulatory submissions
- Deep technical expertise in statistical programming for clinical research, with familiarity in CDISC standards, submission-ready deliverables, and modern programming best practices
- Strong decision-making skills and the ability to guide teams through ambiguity while influencing across project teams
- Collaborative leadership style that emphasizes mentorship, knowledge sharing, and developing others
- Experience managing CROs and external programming vendors, including scope, timelines, quality, and budget oversight
- Experience with regulatory standards (FDA 21 CFR Part 11, GxP) and ensuring audit readiness
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