Director, Statistical Programming
Maze Therapeutics
9 hours ago
Remote friendly (South San Francisco, CA)
United States
Clinical Research and Development
Role Responsibilities:
- Define and implement statistical programming strategy, standards, and best practices across development programs.
- Lead the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs).
- Ensure programming infrastructure is robust, scalable, compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility/audit readiness.
- Drive automation and standardization of programming workflows.
- Partner with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define requirements, align deliverables, and ensure data integrity.
- Represent statistical programming in cross-functional meetings and strategic initiatives.
- Manage CROs and external programming vendors (scope, timelines, quality, budget oversight) and support outsourcing strategy/vendor selection.
- Report to the VP of Biometrics; lead strategy and day-to-day execution across multiple clinical studies.
Qualifications:
- Advanced degree in Statistics, Computer Science, Mathematics, or related.
- Master’s + 10+ years experience, or Ph.D. + 8+ years experience.
- Track record leading statistical programming across multiple clinical studies or regulatory submissions.
- Strong decision-making in ambiguity; collaborative leadership with mentorship and knowledge sharing.
- Deep technical expertise in clinical research statistical programming; familiarity with CDISC standards, submission-ready deliverables, and modern programming best practices.
Hybrid/Onsite:
- Hybrid; onsite at South San Francisco headquarters at least three days per week.
Benefits (explicitly stated):
- Competitive medical, dental, and vision insurance; mental health offerings; equity incentive plan; 401(k) match; generous holiday and PTO; annual performance bonus.
- Define and implement statistical programming strategy, standards, and best practices across development programs.
- Lead the design, development, validation, and maintenance of SAS macros, scripts, and applications supporting clinical data analysis, reporting, and regulatory deliverables (e.g., SDTM, ADaM datasets, TLFs).
- Ensure programming infrastructure is robust, scalable, compliant with regulatory standards (e.g., FDA 21 CFR Part 11, GxP), and supports reproducibility/audit readiness.
- Drive automation and standardization of programming workflows.
- Partner with Biostatistics, Clinical Data Management, Regulatory Affairs, and IT to define requirements, align deliverables, and ensure data integrity.
- Represent statistical programming in cross-functional meetings and strategic initiatives.
- Manage CROs and external programming vendors (scope, timelines, quality, budget oversight) and support outsourcing strategy/vendor selection.
- Report to the VP of Biometrics; lead strategy and day-to-day execution across multiple clinical studies.
Qualifications:
- Advanced degree in Statistics, Computer Science, Mathematics, or related.
- Master’s + 10+ years experience, or Ph.D. + 8+ years experience.
- Track record leading statistical programming across multiple clinical studies or regulatory submissions.
- Strong decision-making in ambiguity; collaborative leadership with mentorship and knowledge sharing.
- Deep technical expertise in clinical research statistical programming; familiarity with CDISC standards, submission-ready deliverables, and modern programming best practices.
Hybrid/Onsite:
- Hybrid; onsite at South San Francisco headquarters at least three days per week.
Benefits (explicitly stated):
- Competitive medical, dental, and vision insurance; mental health offerings; equity incentive plan; 401(k) match; generous holiday and PTO; annual performance bonus.