Madrigal Pharmaceuticals

Senior Director Biostatistics

PA - Conshohocken - Office, USA · Director · Full-time

Sponsorship not specified$264k-$322kDetected 27 days ago

StatisticsCompensationClinical TrialsClinical ResearchFDA RegulatoryResearchCommunicationBiostatistics

About the role

Every member of our Madrigal team is connected by our shared purpose: leading the fight against 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).

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
Establish strong working relationships with external CRO and vendor partners
Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH.
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 position will be a combination of conducting complex statistical analyses, developing SAPs and contributing to regulatory documents.

Ph.D. in Statistics or Biostatistics with 10+ years of experience in Pharma or Biotech companies
In-depth knowledge of regulatory guidelines in pharmaceutical development
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
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.

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.
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.

This listing is sourced directly from Madrigal Pharmaceuticals's careers page and normalized into a canonical job model.