– 12 month renewable remote contract
The Epidemiologist role will support and be an extended member of the Global Epidemiology team. The candidate is expected to contribute to the design and execution of pharmacoepidemiologic studies, provide real-world evidence and insights to global teams and contribute to scientific strategy for pipeline programs and marketed products. Some key areas of contribution expected for the Epidemiologist include: (a) designing and leading epidemiologic studies using various data sources; (b) characterizing descriptive epidemiology of diseases and indications; (c) contributing to the development and execution of pharmacoepidemiologic safety outcomes studies; and (d) communicating study design and results effectively.
The candidate is expected to have and maintain an excellent understanding of epidemiologic data sources and methods and apply them to address program needs.
- Provides epidemiologic data (incidence/prevalence) to support internal forecasts for potential in-licensing products.
- Guides epidemiologic/real-world data (RWD) analyses that contribute to asset-specific forecasts.
- Demonstrates creativity and independent thought in applying technical solutions to derivation of epidemiologic inputs to asset forecasts.
- Contributes to the scientific direction of an asset and/or specific projects.
- Develops epidemiology forecasting estimates of specific addressable patient populations using various epidemiology sources (i.e., analyses of claims, electronic health record [EHR] data, or from syndicated or publicly available sources such as disease registries, NHANES, census data, or scientific literature).
- Conducts descriptive epidemiologic analyses to characterize the incidence/prevalence of diseases (and indications) in the US, as well as selected countries in Europe, Latin America, and Asia.
- Develops the epidemiology section of Orphan Drug Applications or related regulatory documents (for FDA, EMA) where details on disease incidence/prevalence are required.
- Evaluates, synthesizes, and communicates the epidemiology literature on any topic in both written and presentation formats.
- Efficiently provides epidemiology evidence under abbreviated timelines to support prioritized internal business-development related decisions.
- Leads or contributes to the development of new evidence from study design, protocol development, to statistical analysis plans and interpretation of results.
- Supports study start up and collaboration logistics including developing relationships with internal and external collaborators and data partners.
- Guides aspects of study analyses, developing the statistical analysis plans, from secondary sources such as using administrative claims or electronic health record data, as needed.
- Communicates study design and results effectively to diverse internal and external partners.
- Can work independently to deliver results but works successfully with a cross-functional teams around a common goal (e.g., forecasting); able to lead these cross-functional efforts.
- Works in collaboration with fellow Epidemiology colleagues, as well as members of global commercial development, HEOR, marketing, development, safety, regulatory, and other teams.
- Understands current and future polices, practices, trends, developments in information affecting his/her business and organization; knows the competition; is aware of how strategies and tactics work in the marketplace.
- Understands the role of epidemiology in signal evaluation and where epidemiology contributes to key safety and regulatory deliverables.
- Maintains high-level understanding of U.S. and international safety regulations and current regulatory safety review processes.
- Preferred: MPH or MS with more than 10 years of pharmaceutical or biotechnology company experience in epidemiological field (and/or combined experience with biomarker/genomics data analysis); or MD/PharmD/PhD with 3-5 years of experience in the field of epidemiology, outcomes research or related discipline. Minimum requirements: MPH or MS with more than 7 years of demonstrated epidemiological experience in biotech/pharma; or MD/PharmD/PhD with 2 or more years of experience in the field of epidemiology, outcomes research or related discipline.
- Expertise in the analysis of large datasets to enable human translational research and awareness of the limitations and challenges of working with these datasets to advance scientific knowledge.
- Ability to establish productive collaborations with key stakeholders, and co-investigators.
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