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.
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