Epidemiologist

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 Conduct analysis on claims/EHR data using SAS and or R 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 Experience using SAS and or R for analysis of claims data and/or electronic medical records. Experience with advanced statistical methods such as survival and regression Preferred Qualifications: Prior 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