FSP Senior Epidemiologist (Inflammation)
About The Position
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 Lead the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers. Lead effective communication of study/analysis results to support internal and external decisions Coauthor abstracts and manuscripts for external dissemination of methodologic study results Demonstrated ability to manage stakeholders including external vendors and internal cross-functional teams The ideal candidate will bring strong epidemiologic methodologic expertise, a track record of designing innovative RWE studies, and the ability to translate complex data into actionable insights for internal and external stakeholders
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 seven (7) years of experience in lieu of PhD may be acceptable.
- 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 experience in both secondary database studies and primary data collection, including electronic medical record and/or medical claims databases
- Specifically, experience working with commercially available US datasets and data platforms
Nice To Haves
- Background in chronic autoimmune inflammatory conditions such as Rheumatoid arthritis, atopic dermatitis, lupus and asthma
- Experience in innovative study designs, such as synthetic control arms, external comparators, and hybrid RWD-clinical trial approaches, to support clinical development and regulatory decision-making
- A record of scientific publications demonstrating expertise in observational study design, analysis, and interpretation
- Demonstrated ability to function with an increasing level of autonomy and to develop productive cross-functional collaborations in a matrix environment
- Ability to manage priorities and performance targets
Responsibilities
- Design and conduct epidemiological studies to generate real-world evidence within time, budget, and quality standards
- 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
- Lead the communication of observational research results and methods, including development of pertinent sections of regulatory documents, reports, publications, white papers.
- Lead effective communication of study/analysis results to support internal and external decisions
- Coauthor abstracts and manuscripts for external dissemination of methodologic study results
- Demonstrated ability to manage stakeholders including external vendors and internal cross-functional teams
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
