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 World Evidence and Epidemiology as Investigators Meetings KOL Key Opinion Leader meetings Regulatory Agencies Responsible to drive the agenda for generating RWE out of RWD real world data Thereby fully exploits the potential of the data to enhance the knowledge of the compound through data driven projects Person-to-go-to in reviewing epidemiological methodological issues on our compounds coming from literature observational studies registries etc Keeps up to date in relevant methodological epidemiological expertise and hereto reviews relevant literature Attends conferences and courses Disseminates literature draft regulatory guidelines or related information to Biometrics and or Clinical Medical Affairs Represents Biometrics in review of HEOR studies pharmacoeconomic models and Global Value Dossiers Contributes to Behavioral Design studies including Adherence studies w wo use of digital means telehealth Supervisory Management Responsibilities Direct Reports None Indirect Reports None Position Accountability Scope Accountable for observational clinical studies design including sample size justification analysis and reporting Accountable for methodological review of applicable affiliate study protocols Accountable for providing epidemiological support for RWE strategies Minimum Education PhD or MSc in Bio Statistics Mathematics Epidemiology or Health economics If degree in Statistics additional training in epidemiology and RWE If degree in Epidemiology additional training in statistics Professional at senior principal level Minimum Experience Training Required Demonstrable expertise in the application of methodology for the design and conduct of observational studies e g registries case-control secondary database pragmatic trials etc Preferably demonstrable experience in turning Real World Data into Real World Evidence by means of advanced statistical techniques e g Target Trial Emulation G-computation E-values and Targeted Maximum Likelihood Estimation At least 5 years in pharmaceutical workplace Experienced in conducting statistical analyses e g SAS and or R Able to explain epidemiological concepts to non-technical people Knowledge of HEOR would be advantageous Knowledge of behavioral science adherence models would be advantageous The base pay for this position is N A In specific locations the pay range may vary from the range posted JOB FAMILY Research and Discovery DIVISION EPD Established Pharma LOCATION India Mumbai Mumbai Development Center - EPD ADDITIONAL LOCATIONS WORK SHIFT Standard TRAVEL Not specified MEDICAL SURVEILLANCE Not Applicable SIGNIFICANT WORK ACTIVITIES Continuous sitting for prolonged periods more than 2 consecutive hours in an 8 hour day