Senior Epidemiologist

Senior Epidemiologist

Role Expectations

• Generate Evidence Plan for a new molecule and/or disease area with cross-functional drug development teams

• Assess RWD and clinical trial datasets for new molecule and/or disease area

• Support launch planning using RWE/RWD

• Support regulatory submissions and respond to regulatory queries

• Develop proposals for post-marketing commitments with the drug development teams and safety

• Participate and contribute in program or study planning meetings

• 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 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

• 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

• (10+) years industry experience as an epidemiologist

• Inflammation or liver disease RWE/RWD experience preferred