Principal / Associate Director, Statistical Programming

Overview Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH). The Principal / Associate Director Statistical Programmer is an individual contributor responsible for leading and/or supporting multiple programming activities across all phases of clinical development, working closely with the Senior Director of Statistical Programming, statisticians, and external CRO partners to ensure all assigned programming deliverables are completed with high quality and aligned with company standards.
Responsibilities Lead and contribute to statistical programming activities across multiple clinical studies and development programs.
Develop, validate, review, and maintain SAS programs used for data access, transformation, analysis, reporting, and regulatory submission activities.
Review CRO deliverables including SDTM, ADaM, tables, listings, and figures (TLFs), Define.xml packages, and submission deliverables to ensure quality, accuracy, and adherence to company standards.
Collaborate cross-functionally with Biostatistics, Clinical Data Management, Regulatory Operations, Medical Writing, Medical Affairs, and Clinical teams to ensure consistent and accurate use of clinical trial data.
Support regulatory submissions including NDA/BLA activities, pooled analyses, integrated summaries of safety and efficacy (ISS/ISE), and responses to regulatory agencies.
Support the development, implementation, and maintenance of programming standards, macros, automation tools, QC procedures, SOPs, working instructions, and submission processes.
Participate in process improvement and automation initiatives to improve programming efficiency, quality, and scalability, including evaluation of AI-enabled solutions.
Collaborate with CRO partners to ensure deliverables are completed according to timelines, quality standards, and regulatory requirements.
Qualifications Bachelor’s degree in Mathematics, Computer Science, Data Science, Statistics, or related life science field (Master’s degree preferred).
10+ years of total relevant experience in the pharmaceutical/biotech industry with prior regulatory submission experience.
Strong SAS programming experience including SAS Macro development; knowledge of R programming is a plus.
Understanding of regulatory guidance and industry standards including ICH and GCP.
In-depth knowledge of CDISC data standards including SDTM and ADaM models, with extensive implementation experience in clinical trials.
Advanced understanding of statistical concepts supporting clinical data analyses.
Prior experience overseeing programming activities delivered by CRO partners.
Experience supporting NDA/BLA submissions, Define.xml, and submission validation processes preferred.
Strong communication, organizational, problem‑solving, and collaboration skills in a cross‑functional environment.
Compensation and Benefits Base salary range is $180,000 – $219,000 per year. All full‑time employees receive equity and a comprehensive benefits package that includes flexible paid time off, medical, dental, vision, life and disability insurance, and 401(k) offerings. Additional voluntary benefits include supplemental life insurance, legal services, and mental health benefits through an Employee Assistance Program. The company also provides other benefits in accordance with applicable federal, state, and local laws.
Equal Opportunity Employer Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristics protected by applicable federal, state, or local law.

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