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