Principal / Associate Director, Statistical Programming

Madrigal Pharmaceuticals•Conshohocken, PA

8d•$180,000 - $219,000

About The Position

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. The Principal / Associate Director Statistical Programmer is an individual contributor responsible for leading and/or supporting multiple programming activities for Madrigal Pharmaceuticals across all phases of clinical development. This role will work closely with the Senior Director, Statistical Programming, statisticians, and external CRO partners to ensure all assigned programming deliverables are completed with high quality and aligned with company standards. The incumbent will translate statistical objectives into relevant work products, establish programming strategies, and ensure quality execution. The position will combine hands-on programming, development of programming plans, and contribution to regulatory submissions and related documents. In addition to technical execution, the individual will coordinate with biostatisticians, programmers, and CRO partners on the execution of statistical programming deliverables. The individual may partner with the Statistics Lead to manage programming activities for assigned studies or programs, ensuring timelines and quality expectations are met.

Requirements

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.

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.