Senior Epidemiologist (Director)

Details:Pay for this position is 165.00 to 175.62 hourly depending on experience.This position a one year contract with the possibility of extension or conversion to permanent.

Notes/Requirements:VERY High Visible Role, will be supporting an acquisition.Candidate needs to come from a Director or Sr. Director position with leadership skills and experience leading Programs within Molecular and Imflam. Experience with integration and post-launch.

ExperiencePhD in Epidemiology or related field. (10+) years industry experience as an epidemiologistInflammation or liver disease RWE/RWD experience preferred

Summary - Senior EpidemiologistGenerate Evidence Plan for a new molecule and/or disease area with cross-functional drug development teamsAssess RWD and clinical trial datasets for new molecule and/or disease areaSupport launch planning using RWE/RWDSupport regulatory submissions and respond to regulatory queriesDevelop proposals for post-marketing commitments with the drug development teams and safetyParticipate and contribute in program or study planning meetingsPerform feasibility analysis for studiesPlan observational studies and draft protocol synopsis (or protocol concept sheet)Determine observational study design criteria – including source data, analytical methods and analysis plansDraft and review observational study protocolsDraft and review observational study analysis specifications, including statistical analysis plans (SAPs)Draft and review observational study reportsConduct observational studies, both primary data collection and secondary data use studiesReview analysis outputs for quality, including study analysis, ad hoc analysis, analysis to support conference or publicationsConduct quality review of all deliverables to ensure data and results are accurateWork with scientific and operational stakeholders to identify and resolve issuesCollaborate with study teams, vendors and other stakeholders to advance study and analysis deliverablesWork with relevant stakeholders to meet study milestones and timelinesActively adapt and adjust priorities to ensure timely and quality completion of assigned tasksPerform other related duties as required by the Department.