The Real World Evidence (RWE) Contract Epidemiologist will provide leadership for scientific prospective and retrospective activities in the RWE team supporting Sarepta. The RWE Contract Epidemiologist 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.
Key Responsibilities:
- 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
- Maintains knowledge & skills on evolving epidemiological methods, tools & data sources.
- Supports safety epidemiology-related scientific work
- Performs other related duties as needed
Education and Skills Requirements:
- 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
- Key Skills, Abilities and Competencies:
- 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
- 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
- Sarepta Therapeutics offers competitive compensation
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