Senior Director Biostatistics

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, and premature mortality. Our medication, Rezdiffra (resmetirom), is a once‑daily oral, liver‑directed THR‑β agonist designed to target key underlying causes of MASH and is the first and only FDA and European Commission‑approved treatment for moderate to advanced fibrosis (F2‑F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for compensated MASH cirrhosis (F4c). We build a dynamic, inclusive, high‑performing culture that values scientific excellence, operational rigor, and collaboration.

About the Role

The Senior Director of Biostatistics is an individual contributor who will lead multiple biostatistical activities across all phases of clinical development. The role collaborates with internal and external biostatisticians and programmers to translate R&D objectives into relevant work products, establish statistical strategies, and ensure quality execution. Responsibilities include complex statistical analyses, development of statistical analysis plans (SAPs), and contribution to regulatory documents.

Responsibilities

• Represent and lead the statistics function within Madrigal program teams, driving clinical development strategy.
• Oversee and coordinate with other biostatisticians/programmers within Madrigal or at a CRO to support R&D activities.
• Contribute to clinical/regulatory strategies, submission documents, and lifecycle management activities.
• Perform complex statistical analyses, contribute to protocol development, and prepare SAPs.
• Represent the company at external scientific and industry forums.
• Engage with external clinical and statistical thought leaders.
• Establish effective collaborations with cross‑functional project team members (clinical research, clinical operations, data management, pharmacovigilance).
• Build strong relationships with external CRO and vendor partners.
• Mentor and contribute to development of junior R&D team members.

Qualifications

• Ph.D. in Statistics or Biostatistics with 10+ years of experience in pharmaceutical or biotechnology companies.
• Proven experience supporting NDA regulatory submissions and meetings with health authorities (e.g., FDA, EMA, PMDA).
• Expertise in advanced statistical methods and clinical trial design, able to conduct them as needed.
• Effective communication of complex statistical analyses to non‑statisticians.
• In‑depth knowledge of regulatory guidelines in pharmaceutical development.
• Excellent organizational and communication skills.

Total Rewards

• Base salary: $264,000 – $322,000 per year, based on qualifications, skills, education, experience, business needs, and market demands.
• Equity: All full‑time employees receive equity, fostering an ownership culture and providing meaningful opportunity to share in company success.
• Bonus: Performance‑based bonus opportunities.

Benefits

• Flexible paid time off.
• Medical, dental, vision, and life/disability insurance.
• 401(k) with traditional, Roth, and employer match options.
• Supplemental life insurance, legal services, and additional voluntary benefits.
• Mental health benefits via Employee Assistance Program for employees and families.

Equal Opportunity & Accommodation

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 characteristic protected by applicable federal, state, or local law. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact View email address on click.appcast.io.

Application Process

Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site.