Position is Fully Remote
Responsibilities:
Epidemiology & Disease Characterization
Characterize the epidemiology of rare and complex diseases, including:Incidence and prevalencePatient population estimation and sizingSupport epidemiologic analyses for regulatory submissions and strategic planning.Conduct systematic literature reviews and evidence syntheses. Develop evidence packages supporting:
Benefit-risk assessmentsRegulatory briefing documentsScientific narrativesReal-World Evidence StrategyDesign and interpret real-world evidence (RWE) studies to complement clinical trial findings.Support evidence generation strategies in regulatory, lifecycle management, and post-approval settings.Translate complex evidence into regulatory-grade scientific insights. Requirements:
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