Primary Job Function:
Coordinates, provides and delivers methodological and statistical expertise for the design and analysis of clinical studies and clinical development programs. In this matter supports all Affiliates in the Region, thereby complying with international, regulatory guidelines and EPD policies and standards. Directs the operational aspects of statistical work as outsourced to CROs.
Core Job Responsibilities:
Manages several projects and works in more than one therapeutic area.
Attends and presents at external meetings for Statistics (as Investigators Meetings, Regulatory Agencies, Advisory Boards).
Provides adequate and qualified statistical and methodological support to the respective EPD Region, eg input into Clinical Development Plans, and clinical study protocols. 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.
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 Blind Data Reviews, review of study report tables, listings and figures. Incumbent approves the lock of the database and requests unblinding of the study for subsequent analysis. Together with the Clinician, 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 questions related to the file.
For purpose of integrated analyses of internal compound data bases that are accumulating, incumbent writes the strategic and more detailed integration plans in co-operation with Clinical and ensures proper execution.
Fully exploits the potential of the data in order to enhance the knowledge of the compound through data integration and data utilization activities (meta-analyses, data explorations).
Manage external study statisticians working on the analysis of EPD clinical trial data. Briefs CRO’s on methodological and statistical deliverables.
Reviews statistical literature and attends conferences and courses in order to ensure a high statistical expertise and maintain proficiency: Works with other statisticians to acquire knowledge on new/improved statistical methodology. Keeps up to date in relevant statistical expertise and clinical content expertise.