Senior Epidemiologist Consultant

1 week ago

Parsippany, United States Planet Pharma Full time

This will be a VERY Highly Visible Role. It will be supporting an acquisition of a company. Candidates need to come from a Director or Sr. Director position with leadership skills and experience leading Programs within Molecular and Inflammation, and experience with integration and post-launch.

Location:

Foster City, CA (preferred), Parsippany, NJ (preferred), or REMOTE Type:

1-year contract, extendable and open to extension/conversion down the line

Open to remote, but preferred to be onsite in Foster City or NJ

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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