Epidemiologist

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Long term FSP engagment

Responsibilities:

• Support targeted epidemiologic research in specific disease areas, including systematic literature reviews, NH of disease for business development and early development indications
• Contribute to registry strategy for early development and early clinical indications to support BOI for clinical endpoints or NH of disease needed for regulators and clinical development
• Lead and execute evaluation of available registries and other data sources related to BOI or NH
• Determine potential use of RWE historical control within clinical development program and feasibility of obtaining data required for historical control
• Assist in the development of novel RWE tactics proposed for programs currently in clinical development based on cross-functional program needs
• Support execution of approved RWE tactics within assigned indications
• Support Study Execution Teams for observational studies
• Develop draft protocol concept and related materials for review and approval by NIPPRC and Statistical Review Forum
• Contribute to development of performance metrics and dashboards for RWE projects
• Support RWE on relevant GMDA Sub-Teams, Program Teams, or Disease Strategy Teams where studies related to RWE, clinical BOI, or NH are discussed
• Represent RWE on cross-functional collaborations and working groups for pipeline product(s)
• Utilize strong communications skills and understanding of strategies to promote and translate RWD/RWE methods and activities across the company
• Contribute to company publications strategy via development of conference abstracts, presentations, peer-reviewed manuscripts based on the findings of RWE studies

Minimum Qualifications:

• PhD in Epidemiology strongly preferred; will also consider a Master’s level candidate that is methodologically strong.
• Experience in conducting epidemiology or health services studies in any settings, e.g., industry, non-profit, government, or academia. 
• Formal training in Epidemiology/Health Services Research required
• Minimum 3 years of experience working in observational research within the life sciences industry or relevant academic, government, or consulting environment
• Extensive experience with registry data and/or claims data and/or electronic medical records.

Preferred Qualifications:

• Good amount of pharma experience (inside a company)
• Understanding of the 21st Century Cures Act and the opportunities for use of RWE to inform regulatory decision makers
• Demonstrated ability to design and execute observational research
• Strong interpersonal communication and study management skills
• Ability to take detailed observational study results and communicate them in a clear, non-technical manner to internal cross-functional teams, using language that resonates with the teams, while maintaining the integrity of key findings
• Ability to work effectively in a constantly changing, diverse, and matrix environment

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