“Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is headquartered in Radnor, Pennsylvania. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky”
Mineralys is a fully remote company.
Director Statistical Programmer
The Director Statistical Programing (SP) reports to the SVP, Biometrics and is accountable for the production of SDTM and ADAM datasets and Tables, Listings, and Graph output (TFLs) for clinical studies. They will collaborate with partner functions in the Clinical Development Department (e.g. Clinical Operations, Clinical Research, Biostatisticians). They will be accountable for Medical Affairs support by providing output for posters, presentations, and publications.
Key Responsibilities:
- Accountable for all core SP deliverables (SDTM, ADAM, TFLs)
- May also be accountable for clinical programming tasks (creation of SDTM and complex edit checks)
- Provides ongoing data review by providing programmed edit checks, risk-based monitoring metrics, and draft TFLs
- With IT, defines our programming environment and its validation
- Responsible for the development of standards, SOPs, and best practices
- The role is a combination of vendor oversight, supervision of more junior statistical programmers, and some hands-on work.
- The Director SP will supervise assigned junior programmers, both contractors and regular staff members.
Qualifications
- 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.
- Experience with FDA submissions and the provision of data submission packages
- Experience in multiple areas outside of clinical development (e.g. pre-clinical, medical affairs, RWE)
- Deep knowledge of the SAS programming language
- Demonstrated accomplishments in automatization (usually through SAS macro development)
- Working knowledge of at least one other programming language, preferably R
- Experience with using genAI to create programming code or data processing algorithms.
- Ability to work in an interdisciplinary team in a collaborative way
- Represents biometrics in a positive and professional manner
- Ability to work in a fast-paced team environment with fluctuating priorities
- Common sense and solution-oriented mindset
- Intellectual curiosity with a sense of pragmatic implementation of new ideas
- Ability to communicate effectively in English, both orally and in writing.
Core Competencies
- Strong understanding of clinical development processes and regulatory expectations
- Ability to lead and influence in a matrixed environment
- Demonstrated ability to balance urgency with quality
- Analytical rigor with a pragmatic, execution-oriented mindset
Travel
- This position requires up to 10% travel. Frequently travel is outside the local area and overnight.
This position is eligible for standard Company benefits including medical, dental, vision, time off and 401K, as well as participating in Mineralys incentive plans are contingent on achievement of personal and company performance. Actual compensation may vary from posted hiring range based on geographic location, work experience, education, and/or skill level.
US Salary Range: $235,000 - $248,000
#LI-Remote
Skills Required
- BS/BA degree with 10+ years analyzing clinical data OR MS in statistics (or related) with 7+ years analyzing clinical data
- Experience producing SDTM, ADAM datasets and Tables, Listings, and Figures (TFLs)
- Deep knowledge of the SAS programming language
- Demonstrated automation experience, typically via SAS macro development
- Working knowledge of at least one other programming language, preferably R
- Experience with FDA submissions and preparation of data submission packages
- Experience using generative AI to create programming code or data processing algorithms
- Experience across multiple areas outside clinical development (pre-clinical, medical affairs, RWE)
- Experience supervising or providing vendor oversight for junior statistical programmers
- Ability to communicate effectively in English, orally and in writing
What We Do
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing lorundrostat, a proprietary oral aldosterone synthase inhibitor, to treat uncontrolled and resistant hypertension and related cardiorenal disorders (including CKD and OSA). The company focuses on targeted therapies for diseases driven by dysregulated aldosterone and is advancing late-stage clinical programs and regulatory filings to bring this treatment to patients.
