Epidemiologist

Could you be our next Epidemiologist? This position is located in our King of Prussia PA or Waltham MA office. It is a Hybrid role three days onsite. Responsibilities You will lead designated products proactively define epidemiology research strategies to contribute to R&D and Commercial Development objectives. Plan, coordinate and execute all aspects of epidemiology research programs/studies, including protocol development, data collection, data management, data analysis, report generation, vendor management. Prepare results for internal decision making, regulatory agency submissions, publications and technical reports. Contribute epidemiological data in routine and ad hoc regulatory submissions documents (e.g., protocols, Product Clinical Development Plans, Risk Management Plans, Risk Evaluation and Mitigation Strategies, Periodic Safety Update Reports, Development Safety Updates, responses to Health Authority questions and requests). Lead structured benefit-risk assessments, using qualitative and quantitative methods. Contributes strategic and technical expertise in advancing the generation and utilization of RWE across the company. Qualifications Doctoral degree in epidemiology or related quantitative discipline preferably with post-doctoral experience in the pharmaceutical industry or Contract Research Organizations with a pharmaceutical company customer base. Or, Master’s degree in epidemiology or related quantitative discipline with at least 3 years of post-graduate experience in the pharmaceutical industry or Contract Research Organizations with a pharmaceutical company customer base. Demonstrated ability to independently carry out assigned duties, troubleshoot and identify technical and operational problems in the execution of duties, and to independently pursue solutions to ensure objectives are met efficiently and in a timely manner. Experience working successfully in cross-functional teams or in a matrix organizational structure. Experience in conducting high-quality comprehensive literature reviews and critically interpret epidemiologic data and publications. Knowledge of drug or vaccine development process. Proven ability to plan for the optimal, fit for purpose application of epidemiological research in product development and post-marketing support for multiple products with some supervision.

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