RWE Epidemiology Contractor

The Real World Evidence (RWE) Epidemiology Contractor RWE will provide leadership for scientific prospective and retrospective activities in the RWE team supporting Sarepta. The Real World Evidence (RWE) Epidemiology Contractor RWE will function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Market Access, Medical, Research and Legal.

Primary Responsibilities Include:

• Supports and works collaboratively as well as independently with the Directors and RWE lead positions
• Supports retrospective and prospective study development, implementation, and interpretation
• Leads assessment, interpretation & communication of relevant scientific literature; maintains awareness of internal & external data resources & identifies appropriate studies for addressing questions of interest, independently performs data queries & summarizes epidemiologic information.
• Leads ad hoc scientific requests including targeted literature reviews, data analytics, and data interpretation
• Contributes to and/or reviews RWE content for study protocols, SAPs, study reports, slide decks, abstracts, posters, publications, and other presentations of scientific findings.
• Collaborates with other functional groups (e.g. Medical, Commercial, Regulatory Affairs) in preparing documentation for reimbursement agencies or other external organizations.
• Contributes to integration of RWE into the R&D clinical development process & post-marketing activities via participation in cross-functional clinical trial, clinical development, and global development teams, as well as RWE subteams.
• Maintains knowledge & skills on evolving epidemiological methods, tools & data sources.
• Supports safety epidemiology-related scientific work
• Performs other related duties as needed.

Desired Education and Skills: 

• MSc. or Ph.D. or Sc.D. Epidemiology/Pharmacoepidemiology or MPH with experience in sources of real-world evidence and scientific research in the pharmaceutical industry.
• At least two years’ experience in real world evidence research. 
• Experience with rare disease and/ or muscular dystrophy is a plus.
• Ability to use or interpret results from data analysis or signaling software tools. 
• Analytic skills for interpretation of RWE studies.
• Advanced competencies in data analysis in MS Excel, SAS or R. IHD experience a plus.
• Strategic risk management planning. 
• Ability to work in a cross-functional team environment.  
• Capable of problem-solving and creative thinking over a diverse scope of analytic and data related tasks.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Candidates must be authorized to work in the U.S.
• Sarepta Therapeutics offers competitive compensation.
• Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.