Lead Pharmacoepidemiologist

Job Overview:

Minimum 8-year experience in epidemiology pharmacoepidemiology non-interventional studies (prospective studies patient registries retrospective database studies) RWE generation in biopharmaceutical industry or CROs.
Reports directly to the FSP Fortrea Line Manager.
Receives projects-specific requests and strategic-operational guidance from the Head of Clinical Innovation Head of Clinical Feasibility.

Summary of Responsibilities:

• Critically appraise existing epidemiology evidence and create new evidence through delivery of specific research questions/protocols and analysis of healthcare databases.
• Conceive and design epidemiological studies aimed at improving disease understanding relevant to Target Product Profile definition and product development: incidence prevalence risk factors natural history course treatment patterns co-morbidities co-medications outcome measures phenotypes biomarkers unmet needs and their variations across domains such as demographics and geographies.
• Lead the definition of the RWE part of the Global Clinical Development Plan both pre-approval and post approval (e.g. PASS).
• Identify RWE approaches to optimize clinical development during study design (e.g. synthetic arms pragmatic trials hybrid trials etc) and execution (e.g. RWE approaches for protocol feasibility assessment site/physicians identification etc).
• Contribute to the Evidence Generation Plans to build the project/product value proposition by designing observational studies epidemiological studies retrospective and prospective clinical registries large electronic medical administrative registries.
• Perform feasibility assessments and identify fit-for-purpose data for RWE research.
• Develop RWE research plans in collaboration with external collaborators in academia or contract research organizations and work effectively with vendors for outsourced studies based on both primary and secondary data collection or hybrid approaches including research question/protocol development and analysis specification following best methodological standards.
• Drive the interpretation of analysis in collaboration with the cross-functional team and communicate analysis interpretation internally and externally.
• Contribute to publication and dissemination of pharmacoepidemiology studies.

As pharmacoepidemiology subject matter expert:

• Collaborate with Scientific Societies on Disease Registries to maximise the value extraction from their development and interrogation.
• Provide critical appraisal of observational studies and study protocols across the company.
• Support and advise scientifically and from a methodological point of view on Real World Evidence strategies across multiple projects as subject matter expert.
• Master Pharmacoepidemiology/RWE science and expertise by continuous learning training and working.
• Interact and contribute to functional cross-functional company-wide or external Pharmacoepidemiology/RWE communities networks collaborations initiatives or goals on knowledge-sharing methodologies innovations technology regulatory processes etc.
• Provides support to the Clinical Innovation Unit interacting with RWE Project management Lead Clinical Feasibility Head and Clinical Digital Health lead/manager

Learn more about our EEO & Accommodations request here.