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 (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 (Target Trial Emulation, G-computation, E-values, and Targeted Maximum Likelihood Estimation).

- At least 5 years in pharmaceutical environment.

- Experienced in conducting statistical analyses (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.