Job Title - Epidemiologist / Sr Mgr Drug Sfty & Publ Hlth
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