Executive Director, Biostatistics

Madrigal is a biopharmaceutical company pursuing novel therapeutics for non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). Our first therapy, Rezdiffra (resmetirom), was granted accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of adults with NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) and is being studied in a Phase 3 trial for the treatment of NASH with compensated cirrhosis.

The Executive 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 Chief Data and Analytics Officer of Madrigal Pharmaceuticals.

POSITION RESPONSIBILITIES: 

• This role will 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
• Represents the company in external scientific and industry forums.
• Engages in interactions with both external clinical and statistical
• thought leaders
• Establishes effective collaborations with cross-functional project
• team members, such as clinical research, clinical operations, data
• management and pharmacovigilance
• Establishes strong working relationships with external CRO and
• vendor partners
• Mentors and contributes to more junior members in R&D

QUALIFICATIONS AND SKILLS REQUIRED:

• 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
• This role will be 3 days per week onsite in Conshohocken, PA. We are open to considering candidates willing to relocate.
   

Compensation: Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.

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.

Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established.

Please be aware that we are currently receiving numerous reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals’ Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal’s name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does