The Senior Director of Biostatistics is an individual contributor that will lead multiple biostatistical activities for Madrigal Pharmaceuticals, covering all phases of clinical development. This role will collaborate with other biostatisticians and programmers either in the company or at a CRO to ensure meeting R&D objectives.

The incumbent will translate R&D objectives into relevant work products, establish statistical strategies and ensure quality execution. The position will be a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents. In addition to hands-on work, the incumbent will also coordinate with other biostatisticians/programmers on execution of other statistical deliverables

This position reports into the SVP, Biostatistics and Data Sciences of Madrigal Pharmaceuticals.

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 pharmacovigilence
• 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 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

Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. As of the date of this posting, a good faith estimate of the current pay scale for this position, applicable to all candidates, is $264,000 - $322,000 per year. We comply with all applicable minimum wage laws.

All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization.

Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws.