Job Description

About the Role

In this role, one must collaborate with global clients and cross-functional teams to provide epidemiology expertise for real-world evidence (RWE) studies across the full spectrum of study designs and methodologies, spanning early clinical development through post-approval stages. Support research initiatives including, but not limited to, natural history of disease studies, external comparator studies, and comparative safety and effectiveness evaluations of drugs, biologics, and medical devices under the guidance of senior staff.

Design scientifically rigorous and methodologically sound studies that align with project objectives and stakeholder requirements, including regulatory and payer expectations. Contribute to data collection strategy through input on eCRF design, feasibility assessments, and data landscape evaluations. Conduct and review analyses, interpret study findings, and support the preparation of study reports and other deliverables. Responsibilities may range from providing feasibility insights to developing study protocols and clinical study reports, while ensuring data quality, scientific integrity, and operational excellence throughout all phases of real-world studies. May also contribute to business development activities to support client retention and growth opportunities.

Key Responsibilities

• Lead the design, implementation, and execution of epidemiology and pharmacoepidemiology methodologies for real-world evidence (RWE) studies, including drug safety, comparative effectiveness, observational, and low-intervention research utilizing real-world data sources.
• Provide scientific and methodological expertise to support research initiatives and strategic projects in collaboration with senior team members.
• Serve as the project lead for smaller studies and work closely with senior project leaders on larger client-facing and internal projects.
• Develop and author study protocols, statistical analysis plans, clinical study reports, and other research documentation, ensuring high standards of scientific quality, accuracy, and completeness.
• Manage analysis and reporting deliverables, maintaining project timelines and identifying risks or issues requiring escalation when appropriate.
• Review study analyses and provide epidemiological input into statistical analysis plans, analytical outputs, and interpretation of study findings.
• Contribute epidemiological expertise to case report form (CRF/eCRF) design, form review, feasibility assessments, regulatory responses, presentation materials, and other ad hoc project activities.
• Engage directly with clients to discuss study design, methodology, results, and project progress, with senior oversight as needed.
• Identify and proactively address project, client, budgetary, and operational challenges to support successful project delivery.
• Ensure efficient use of project resources and work within approved budgets while maintaining quality standards.
• Drive continuous process improvement initiatives and contribute to the development and implementation of best practices across epidemiology and observational research teams.
• Support business development efforts through proposal development, scientific input, and content creation for new opportunities.
• Represent the organization externally through scientific conferences, professional meetings, publications, and presentations.
• Oversee or conduct statistical analyses, as required, to support study objectives and deliverables.
• Contribute to internal strategic initiatives aimed at enhancing scientific excellence, methodological innovation, and operational effectiveness.