Senior Director Biostatistics

Responsibilities

This role will represent and lead the statistics function within Madrigal program teams, working cross-functionally to drive program clinical development strategy.

Oversee and coordinate with other biostatisticians/programmers either within Madrigal or at a CRO in support of executing R&D activities.

Contribute to clinical/regulatory strategies, submission documents and lifecycle management activities to ensure the company’s clinical programs and data assets are optimally designed and executed.

Perform complex statistical analyses, contribute to protocol development and prepare Statistical Analysis Plans.

Represent the company in external scientific and industry forums. Engages in interactions with both external clinical and statistical thought leaders.

Establish effective collaborations with cross-functional project team members, such as clinical research, clinical operations, data management and pharmacovigilance.

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 in supporting NDA regulatory submissions, and meeting with health authorities (e.g, FDA, EMA, PMDA)

Demonstrated expertise in advanced statistical methods and clinical trial design and able to conduct them as needed

Effectively communicates complex statistical analyses and issues to non-statisticians

In-depth knowledge of regulatory guidelines in pharmaceutical development

Excellent organizational and communication skills