JOB DESCRIPTION Primary Job Function Coordinates provides and delivers methodological and epidemiological expertise to Real-World Evidence generation in Abbott s Established Pharmaceuticals Division EPD In this matter supports Clinical Development and or Medical Affairs in clinical studies and related activities on the EPD brands Assures compliance with international and as applicable local regulatory guidelines as well as EPD policies and standards Directs the operational aspects of the methodological work of RWE research projects as outsourced to CROs Core Job Responsibilities Manages several projects mainly RWE occasionally interventional and works across all therapeutic areas Main methodological contributor to the design analysis and reporting of all observational clinical studies such as epidemiological studies surveys as well as nested case-control studies cross-sectional studies registry studies secondary database studies Responsible for appropriate statistical methodology and endpoint definitions as part of the design of clinical studies and for the associated sample size determination Writes and or reviews the statistical part of the protocol to ensure that appropriate statistical methodology is applied to minimize confounding and biases as pre-requisite to turn real world data into real world evidence Responsible for briefing the CRO to an appropriate conduct of statistical analysis of EPD Clinical Development studies This entails review of the statistical analysis plan participation in data reviews review of study report tables listings and figures Incumbent approves the statistical analysis plan and the lock of the database Together with the medical responsible person clarifies and communicates the results and conclusions in order to ensure the correct interpretation of the results by different users Supports dossier submissions and answers statistical and methodological questions related to the file Attends and presents at external meetings for Real Wor

📌 Senior Manager Rwe (Mumbai)
🏢 Abbott
📍 Mumbai