FSP Epidemiologist/Sr Epidemiologist

Description: Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards, including but not limited to: natural history of disease, population characterization, assessment of treatment patterns and unmet need, development of external comparators, benchmarking of clinical outcomes, comparative safety and effectiveness research, and post-authorization studies. Lead development of study protocols, analysis plans, and study reports to answer methodologic questions of priority to RWE. Lead the identification of fit-for-purpose data for the timely execution of the RWE strategy. Construct cohorts using RWD sources (e.g., claims, EHR) and evaluate key variables, including diagnosis and procedures codes, and plan validation studies as needed. Conduct analyses for descriptive and comparative research using RWD for methodologic research questions. Contribute to the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers. Support the effective communication of study/analysis results to support internal and external decisions. Contribute to the development of processes and training aimed at increasing the efficiency, quality, and impact of functional activities. Coauthor abstracts and manuscripts for external dissemination of methodologic study results. Minimum requirements: PhD in Epidemiology or related field with a minimum of four (4) years of relevant post-doctoral experience, preferably in pharmaceutical industry, biotechnology, or consulting environment. Master’s degree in epidemiology or relevant scientific field, plus 7-9 years of experience in lieu of PhD may be acceptable. Deep understanding of observational research methods and experience to support the design and conduct of observational research, including protocol, statistical analysis plan, and study report development. Extensive knowledge of secondary data sources and experience with secondary data analysis, including electronic medical record and/or medical claims databases. A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation is preferred. Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations in a matrix environment. #J-18808-Ljbffr