Senior Director Biostatistics

Responsibilities:
- Represent and lead the statistics function within Madrigal program teams, working cross-functionally to drive program clinical development strategy.
- Oversee and coordinate with biostatisticians/programmers within Madrigal or at a CRO to execute R&D activities.
- Contribute to clinical/regulatory strategies, submission documents, and lifecycle management activities.
- Perform complex statistical analyses; contribute to protocol development and prepare Statistical Analysis Plans (SAPs).
- Represent the company in external scientific and industry forums.
- Establish effective collaborations with cross-functional teams (clinical research, clinical operations, data management, pharmacovigilance).
- Establish strong working relationships with external CRO and vendor partners.
- Mentor and contribute to more junior members in R&D.

Qualifications:
- Ph.D. in Statistics or Biostatistics with 10+ years of experience in Pharma or Biotech companies.
- Proven experience supporting NDA regulatory submissions and meeting with health authorities (FDA, EMA, PMDA).
- Demonstrated expertise in advanced statistical methods and clinical trial design.
- Ability to communicate complex statistical analyses/issues to non-statisticians.
- In-depth knowledge of regulatory guidelines in pharmaceutical development.
- Excellent organizational and communication skills.

Benefits:
- Full-time employees are eligible for flexible paid time off, medical, dental, vision, life/disability insurance, and 401(k) offerings (traditional, Roth, employer match), plus additional voluntary benefits.

Application Instructions:
- Apply via the Madrigal Careers site (applications accepted on an ongoing basis).