Principal Pharmaceutical Epidemiologist, FSP

Principal Pharmaceutical Epidemiologist, FSP

Durham, United States of America | Full time | Home-based | R1536917

Location: Home-based in the U.S. or Canada

Job Overview

Work closely with global clients and other functional groups leadership for real world studies which include but are not limited to the natural history of disease, external comparators, post‑market surveillance, comparative safety and effectiveness of drugs or biologics. Manage multiple pharmacoepidemiology studies of varying complexity and ensure quality and on‑time delivery for clients. Conduct and review analyses, and be responsible for the evaluation and reporting of studies.

May also provide senior epidemiology oversight. Independently design complex methodologically sound studies to meet project objectives and stakeholder requirements (e.g., regulatory, payers, etc.).

Additional Benefits:

• Home-based remote working opportunities.
• Work/life balance as well as flexible schedules.
• Collaborating with motivated, high‑performance, statistical and research teams.
• Technical training and tailored development curriculum.
• Research opportunities that match your unique skill set.
• Promising career trajectory.
• Job stability: long‑term engagements and re‑deployment opportunities.
• Focus on bringing new therapies to market rather than project budgets and change orders.
• Experience with regulatory submissions.
• Engaging, fast‑paced environment.
• Good work‑life balance.

Job Responsibilities:

• Provide a rigorous assessment of the incidence and prevalence of disease targets using literature reviews, database analysis, or extrapolation of estimates.
• Support regulatory submission activities including authoring epidemiology sections of orphan or breakthrough designation applications and dossiers and provide input to the design of post‑marketing commitment studies.
• Partner with patient safety and risk management team to provide input to the Risk Evaluation and Mitigation Strategy, risk management plans (RMPs), and post‑approval safety studies (PASS).
• With moderate oversight, author epidemiology sections of Development Safety Update Reports, Periodic Benefit‑Risk Evaluation Reports and PASS reports. Investigate and understand potential safety signals for marketed RNAi therapeutics.
• Partner with Biostatistics and Statistical Programming to implement, provide input into the analyses from registries, post‑approval safety studies and other observational studies to support regulatory requirements and scientific publications, presentations, and abstracts.
• Independently lead design and implementation of complex epidemiology/ pharmacoepidemiology methods in real world studies and studies using real world data, including (but not limited to) drug safety and effectiveness studies and other observational or low intervention studies using real world data and/or methodology.
• Support senior staff on specific research initiatives as needed.
• Serve as project lead on client facing or internal projects.
• Author protocols, reports, and other study documents with independent, critical thinking to ensure quality and completeness of output, overseeing timeline for deliverables associated with analysis and reporting.
• Review and provide relevant epidemiological input to statistical analysis plans and analysis output.
• Review and provide epidemiology input for tasks including CRF/eCRF development, form previews and other ad hoc project tasks (e.g., regulatory responses, slide deck development).
• Provide senior epidemiology oversight and review work of peers and junior staff in areas including observational study methods, statistical methods, safety and pharmacovigilance, the selection of instruments and clinical measures to achieve objectives, and sources and measures for resource utilization and costing.
• Identify issues that may require attention or escalation.
• May oversee or conduct statistical analysis as needed.
• May contribute to intra- and interdepartmental process improvement to achieve "best practices" and to support effective delivery.
• Remain current on industry, clients, and competitive trends and directions in order to anticipate and identify new business challenges and issues with assigned…