Director, Statistical Programming
New
M
Mineralys TherapeuticsBiopharmaceutical
US RemoteFull-TimeDirector
Salary235,000 - 248,000 USD per year
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Job Details
- Languages
- English
- Experience
- BS/BA degree and 10+ years of experience in analyzing clinical data OR MS in statistics or related area and 7+ years of experience in analyzing clinical data.
- Required Skills
- RGenerative AI
Requirements
- BS/BA with 10+ years experience or MS with 7+ years experience in analyzing clinical data.
- Experience with FDA submissions and data submission packages.
- Experience in areas outside clinical development (e.g., pre-clinical, medical affairs, RWE).
- Deep knowledge of the SAS programming language.
- Accomplishments in automatization via SAS macro development.
- Working knowledge of at least one other programming language, preferably R.
- Experience using genAI to create programming code or data processing algorithms.
- Strong understanding of clinical development processes and regulatory expectations.
- Ability to lead and influence in a matrixed environment.
- Effective oral and written communication in English.
Responsibilities
- Accountable for all core SP deliverables (SDTM, ADAM, TFLs).
- Perform clinical programming tasks including creation of SDTM and complex edit checks.
- Provide ongoing data review through programmed edit checks, risk-based monitoring metrics, and draft TFLs.
- Collaborate with IT to define the programming environment and its validation.
- Develop standards, SOPs, and best practices.
- Oversee vendors and supervise junior statistical programmers.
- Provide output for Medical Affairs posters, presentations, and publications.
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