Sr Mgr Drug Sfty Publ Hlth - IV

Job Title Sr Epidemiologist Mgr Drug Sfty & Publ Hlth
Location Remote or Hybrid based on candidate preference (Manager is based in Parsippany NJ)

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