Director, Statistical Programming
Mineralys Therapeutics, Inc.
June 26, 2026
Remote
United States
Clinical Research and Development
Director Statistical Programmer
Responsibilities:
- Accountable for core statistical programming deliverables: SDTM, ADAM, and TFLs for clinical studies.
- May perform clinical programming tasks including creation of SDTM and complex edit checks.
- Provide ongoing data review via programmed edit checks, risk-based monitoring metrics, and draft TFLs.
- With IT, define the programming environment and its validation.
- Develop standards, SOPs, and best practices.
- Serve as a combination of vendor oversight, supervision of junior programmers, and some hands-on work.
- Supervise assigned junior programmers (contractors and regular staff).
Qualifications/Skills:
- BS/BA with 10+ years’ experience analyzing clinical data OR MS (statistics or related) with 7+ years’ experience.
- Experience with FDA submissions and providing data submission packages.
- Experience across multiple areas outside clinical development (e.g., pre-clinical, medical affairs, RWE).
- Deep SAS programming knowledge; demonstrated automation (e.g., SAS macro development).
- Working knowledge of at least one other programming language, preferably R.
- Experience using genAI to create code or data processing algorithms.
- Strong clinical development/regulatory understanding; able to lead in a matrixed environment.
- Ability to balance urgency with quality; analytical rigor with execution mindset.
- Ability to communicate effectively in English (oral and written).
Benefits:
- Eligible for standard company benefits including medical, dental, vision, time off, and 401K; participation in incentive plans contingent on performance.
- US salary range: $235,000–$248,000.
Travel:
- Up to 10% travel (often outside local area and overnight).
Responsibilities:
- Accountable for core statistical programming deliverables: SDTM, ADAM, and TFLs for clinical studies.
- May perform clinical programming tasks including creation of SDTM and complex edit checks.
- Provide ongoing data review via programmed edit checks, risk-based monitoring metrics, and draft TFLs.
- With IT, define the programming environment and its validation.
- Develop standards, SOPs, and best practices.
- Serve as a combination of vendor oversight, supervision of junior programmers, and some hands-on work.
- Supervise assigned junior programmers (contractors and regular staff).
Qualifications/Skills:
- BS/BA with 10+ years’ experience analyzing clinical data OR MS (statistics or related) with 7+ years’ experience.
- Experience with FDA submissions and providing data submission packages.
- Experience across multiple areas outside clinical development (e.g., pre-clinical, medical affairs, RWE).
- Deep SAS programming knowledge; demonstrated automation (e.g., SAS macro development).
- Working knowledge of at least one other programming language, preferably R.
- Experience using genAI to create code or data processing algorithms.
- Strong clinical development/regulatory understanding; able to lead in a matrixed environment.
- Ability to balance urgency with quality; analytical rigor with execution mindset.
- Ability to communicate effectively in English (oral and written).
Benefits:
- Eligible for standard company benefits including medical, dental, vision, time off, and 401K; participation in incentive plans contingent on performance.
- US salary range: $235,000–$248,000.
Travel:
- Up to 10% travel (often outside local area and overnight).