Principal / Associate Director, Statistical Programming
$180k - $219kMadrigal Pharmaceuticals
Principal or Associate Director of Statistical Programming at a biopharmaceutical company developing treatments for metabolic dysfunction-associated liver disease. The role combines hands-on SAS programming with leadership of clinical trial data analysis activities, regulatory submissions, and cross-functional coordination across multiple development programs.
Responsibilities
- Lead and execute statistical programming activities across multiple clinical studies and development programs
- Develop, validate, and maintain SAS programs for data transformation, analysis, and regulatory submissions
- Review CRO deliverables including SDTM, ADaM, TLFs, and submission packages for quality and compliance
- Support NDA/BLA submissions, pooled analyses, and regulatory agency responses
- Collaborate with biostatisticians, clinical teams, and CRO partners to ensure accurate data use and timeline adherence
Requirements
- Bachelor's degree in Mathematics, Computer Science, Statistics, or related field; Master's preferred
- 10+ years pharmaceutical or biotech industry experience with regulatory submission experience
- Advanced SAS programming skills including macro development; R programming knowledge a plus
- In-depth knowledge of CDISC standards (SDTM and ADaM) with clinical trial implementation experience
- Understanding of ICH, GCP, and regulatory guidance for clinical submissions
- Prior experience overseeing and managing CRO programming deliverables
- Strong cross-functional communication, problem-solving, and collaboration abilities
Compensation: $180,000-$219,000 base per year
Vacancy posted 4 days ago
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