Epidemiologist

Role Expectations

• Perform feasibility analysis for studies
• Plan observational studies and draft protocol synopsis (or protocol concept sheet)
• Determine observational study design criteria – including source data, analytical methods and analysis plans
• Draft and review observational study protocols
• Draft and review observational study analysis specifications, including statistical analysis plans (SAPs)
• Draft and review observational study reports
• Conduct observational studies, both primary data collection and secondary data use studies
• Review analysis outputs for quality, including study analysis, ad hoc analysis, analysis to support conference or publications
• Conduct targeted literature reviews for ad hoc queries/ event frequencies
• Conduct quality review of all deliverables to ensure data and results are accurate
• Work with scientific and operational stakeholders to identify and resolve issues
• Collaborate with study teams, vendors and other stakeholders to advance study and analysis deliverables
• Work with relevant stakeholders to meet study milestones and timelines
• Participate in program or study planning meetings
• Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks
• Perform other related duties as required by the Department.

Experience
• Graduate degree in Epidemiology
• (7 – 10)+ years industry experience as an epidemiologist
• Oncology and safety RWE/RWD experience preferred