Epidemiologist

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
•    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
•   Ability to conduct analysis on claims/EHR data using SAS and or R would be a plus