Epidemiologist

Summary

The Subject Matter Expert (Mid)–Epidemiologist provides scientific, epidemiologic, and technical support to government staff responsible for the review of vaccines and related biological products. The contractor supports regulatory review activities by assisting in the evaluation and interpretation of epidemiologic data, preparation of scientific and regulatory documents, development of briefing materials, and communication of complex scientific information to a variety of audiences.

Essential Duties and Responsibilities

• Support government staff in the review and evaluation of regulatory submissions for vaccines and related biological products, including BLAs, EUAs, supplements, and other regulatory applications.
• Develop and maintain knowledge of FDA review processes, scientific standards, and regulatory requirements applicable to vaccines and biological products.
• Assist in the preparation, editing, and quality review of regulatory and scientific documents, including review memoranda, advisory committee briefing materials, technical reports, regulatory summaries, and responses to information requests.
• Review, interpret, and evaluate epidemiologic data from healthcare claims databases, electronic health records, registries, surveillance systems, and other real-world data sources.
• Audit study designs, methodologies, and analytical approaches; identify data gaps and recommend additional analyses to support regulatory decision-making.
• Synthesize complex scientific, epidemiologic, and public health information into clear, accurate, and actionable conclusions for technical and non-technical audiences.
• Support the development of scientific manuscripts, study protocols, white papers, presentations, and submissions to peer-reviewed journals.
• Develop and maintain visual communication products, including graphs, tables, figures, and infographics, to effectively communicate scientific findings and regulatory information.
• Collaborate with government stakeholders to prioritize assignments, coordinate deliverables, and support time-sensitive regulatory reviews.
• Apply project management principles to manage multiple concurrent assignments, monitor progress, and ensure timely completion of deliverables.
• Ensure all work products comply with applicable federal laws, regulations, agency policies, quality standards, and Section 508 accessibility requirements.
• Maintain confidentiality and adhere to established FDA templates, documentation practices, and review procedures.

Required Experience and Skills

• Minimum of seven (7) years of experience conducting pharmacoepidemiology studies using large healthcare claims databases, electronic health record systems, or comparable real-world data sources.
• Demonstrated experience supporting scientific research, regulatory review activities, or public health programs involving drugs, vaccines, or biological products.
• Experience synthesizing and communicating complex scientific, regulatory, policy, or public health information to diverse audiences.
• Experience managing multiple time-sensitive projects and coordinating activities across stakeholders.
• Post-Doctoral Degree in Epidemiology, Pharmacoepidemiology, Public Health, Biostatistics, Medicine, Pharmacy, Health Outcomes Research, or a closely related scientific discipline.