Principal / Associate Director, Statistical Programming

Madrigal Pharmaceuticals · Conshohocken -, PA

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BiometricsFull-time$180k–$219kCompany career page

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Role summary

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.

What they're looking for

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

What you'll be doing

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

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