Senior Director Biostatistics

Location: Conshohocken

## Senior Director Biostatistics Apply locations:
PA
- Conshohocken
- Office time type:
Full time posted on:
Posted 2 Days Agojob requisition :
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

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