Job Description
Duties and Responsibilities:
- Perform feasibility analysis for studies.
- Conduct literature review.
- 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.
- Conduct study data analysis according to observational methods.
- Conduct data analysis according to observational methods.
- 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.
- Participate in program or study planning meetings.
- Actively adapt and adjust priorities to ensure timely and quality completion of assigned tasks.
- Contribute to ongoing improvement of programming processes and methodology.
- Perform other related duties as required by the Department.
Education and Experience:
- Graduate degree in Epidemiology.
- 7 – 10+ years industry experience as an epidemiologist.
- Oncology RWD/RWE Study Experience preferred.