Associate Principal Scientist, Epidemiology

In BARDS (Biostatistics and Research Decision Sciences), a distinguished department within our company’s renowned Research and Development division, quantitative scientists, in partnership with other subject matter experts, apply state-of-the art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for the benefit of patients and global human health. Under the general direction of the Executive Director of Epidemiology, the Associate Principal Scientist, Epidemiology will lead the worldwide epidemiology strategy for assigned compounds in the General and Specialty Medicine area, specifically in metabolism, immunology or ophthalmology. This role is primarily responsible for the design, execution, analysis, and reporting of epidemiologic research on assigned products. The position also provides consultation on epidemiologic methods, real‑world evidence (RWE) generation, and the interpretation of observational study results across the organization as needed. Primary activities include but are not limited to: Has primary responsibility for the design, execution, and analysis of epidemiologic research studies on assigned company products. May have overall responsibility for worldwide epidemiologic strategy for assigned our company products in the General and Specialty Medicine area, specifically in metabolism, immunology or ophthalmology. Supports the Therapeutic Area (TA) Lead Epidemiologist in shaping the worldwide epidemiology strategy. Leads cross-functional interaction with risk management sub-teams, value evidence sub-teams, clinical, and regulatory sub-teams, and other R&D areas on epidemiologic matters related to product safety, risk management, post-marketing safety studies, regulatory activities, and clinical development for assigned company products. May present epidemiologic research plans or results to internal review and governance committees; to external agencies such as FDA (including advisory committees), EMA, CDC, AHRQ, and WHO; and at scientific conferences. Maintains close working relationships with colleagues in Clinical Research, Regulatory, Safety, Statistics, Outcomes Research, Health Economics and Commercial. Assists them in areas where knowledge of epidemiology is relevant. Contributes to our company's prestige by maintaining recognition as an expert in the field; may publish independent scientific research in leading journals, participate in and present at scientific organizations and meetings, and serve as a peer reviewer for scientific journals. Minimum required education: PhD in Epidemiology, or MD with additional research training in epidemiology, plus at least 3 years of relevant work experience in General and Specialty Medicine area, particularly metabolism, immunology or ophthalmology. Required experience and skills: Proven experience of leading epidemiologic projects using large databases: including national surveys, administrative claims, electronic health records (EHRs), and disease registries. Possess broad knowledge and experience in applying epidemiologic approaches to problems in the pharmaceutical or biotechnology industry. Familiarity with Good Pharmacovigilance Practices (GVP), Good Pharmacoepidemiology Practices, and guidance from FDA/EMA on RWE/RWD. Proven record of publications in peer-reviewed journals. Strong creative problem-solving skills and excellent oral and written communication skills. Ability to work effectively in a cross-functional team environment and collaborate with colleagues with a wide variety of backgrounds and expertise.

And Skills Prior experience in the pharmaceutical or biotechnology industry, or with a CRO, is preferred. BARDS2020 #EligibleforERP Required Skills: Biopharmaceutical Industry, Data Management, Epidemiological Research, Epidemiological Studies, Epidemiology, Immunology, Ophthalmology, Stakeholder Relationship