Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Senior Epidemiologist
Role Expectations
Experience * Graduate degree in Epidemiology
Senior Epidemiologist
Posted: 04/12/2024
2024-04-12
2024-05-19
Employment Type:
Contract
Job Category: Other
Job Number: 603795
Is job remote?: Yes
Country: United States
Job Description
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
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