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 environment
• 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