Senior Epidemiologist

Job Title-Senior EpidemiologistLocation: Foster City ,CA/New Jersey /RemoteClient- Gilead

Senior Epidemiologist

Role Expectations

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

• Experience with Molecular and Imflam. Experience with integration and post-launch
• 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

Job Type: Contract

Salary: $100.00 - $170.00 per hour

Benefits:

• Dental insurance
• Health insurance

Experience level:

• 10 years

Medical specialties:

• Infectious Disease

Schedule:

• 8 hour shift

Work Location: Remote