Senior Manager RWE & Epidemiology

Role Overview: You will be responsible for coordinating, providing, and delivering methodological and epidemiological expertise to Real-World Evidence generation within Abbott's Established Pharmaceuticals Division (EPD). Your primary focus will be to support Clinical Development and/or Medical Affairs in clinical studies and related activities on the EPD brands. You will ensure compliance with international and local regulatory guidelines, as well as EPD policies and standards. Additionally, you will direct the operational aspects of the methodological work of RWE research projects outsourced to CROs. Key Responsibilities: - Manage several projects, mainly RWE and occasionally interventional, across all therapeutic areas - Contribute methodologically to the design, analysis, and reporting of observational clinical studies such as epidemiological studies, cross-sectional studies, and registry studies - Define appropriate statistical methodology and endpoint definitions for the design of clinical studies, including sample size determination - Review and approve the statistical analysis plan, participate in data reviews, and review study report tables, listings, and figures - Collaborate with the medical responsible person to clarify and communicate results and conclusions - Support dossier submissions and address statistical and methodological questions related to the file - Drive the agenda for generating RWE from RWD, leveraging data to enhance compound knowledge through data-driven projects - Review epidemiological and methodological issues on compounds from literature sources - Stay updated on relevant methodological and epidemiological expertise by attending conferences, courses, and reviewing literature - Represent Biometrics in the review of HEOR studies, pharmacoeconomic models, and Global Value Dossiers - Contribute to Behavioral Design studies, including Adherence studies with or without the use of digital means or telehealth Qualification Required: - PhD or MSc in (Bio)Statistics, Mathematics, Epidemiology, or Health economics - Additional training in epidemiology and RWE for Statistics degree holders, and additional training in statistics for Epidemiology degree holders - Professional at senior/principal level - Demonstrable expertise in designing and conducting observational studies - Experience in turning Real World Data into Real World Evidence using advanced statistical techniques - Minimum of 5 years of experience in a pharmaceutical environment - Proficient in conducting statistical analyses using SAS and/or R - Ability to explain epidemiological concepts to non-technical individuals - Knowledge of HEOR and behavioral science/adherence models would be advantageous,