Senior Director Biostatistics

Madrigal; Conshohocken (Montgomery County); On-site; USD 264,000 - 322,000; Full time

Benefits offered by this job

Equity

Flexible PTO

Medical, Dental, Vision Insurance

Life/Disability Insurance

401(k) Plan

Job summary

Madrigal Pharmaceuticals is seeking a Senior Director of Biostatistics to lead multiple biostatistical activities across all phases of clinical development and to translate R&D objectives into robust statistical work products.

The role collaborates with statisticians and programmers in-house or at CROs, develops SAPs, supports regulatory submissions, and mentors junior staff while reporting to the SVP of Biostatistics and Data Sciences.

Qualifications

• Ph.D. in Statistics or Biostatistics with 10+ years of experience in Pharma or Biotech.
• Proven experience supporting NDA regulatory submissions and meetings with health authorities (FDA, EMA, PMDA).
• Demonstrated expertise in advanced statistical methods and clinical trial design.

Responsibilities

• Represent and lead the statistics function within Madrigal program teams, driving clinical development strategy across cross-functional groups.
• Oversee and coordinate with other biostatisticians/programmers within Madrigal or at a CRO for R&D activities.
• Contribute to clinical/regulatory strategies, submission documents and lifecycle management to ensure data assets are well designed and executed.
• Perform complex statistical analyses, contribute to protocol development and SAPs.
• Represent the company in external forums and build collaborations with thought leaders; mentor junior staff in R&D.

Skills

Communication skills

Leadership

Analytical thinking

Education

Ph.D. in Statistics or Biostatistics

Job description

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 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.

Salary & Benefits

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. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process.

Equal Opportunity & Diversity

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.

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.