Director Biostatistician
Posted 2 days ago by Tech Observer
Negotiable
Undetermined
Undetermined
United Kingdom
Summary: The Director Biostatistician is responsible for providing methodological and statistical expertise to support Clinical Development and Strategic Medical Affairs. This role involves managing multiple projects across various therapeutic areas, directing outsourced statistical work, and ensuring compliance with regulatory guidelines. The incumbent will also be involved in statistical analysis, protocol writing, and data integration to enhance knowledge of compounds. Additionally, the position requires collaboration with external study statisticians and participation in external meetings to communicate results effectively.
Key Responsibilities:
- Coordinates and delivers methodological and statistical expertise and analyses.
- Supports Clinical Development and Strategic Medical Affairs in compliance with guidelines.
- Directs operational aspects of statistical work outsourced to CROs.
- Manages multiple projects across various therapeutic areas.
- Attends and presents at external meetings for Statistics.
- Provides statistical and methodological support for Clinical Development Plans and study protocols.
- Responsible for statistical methodology and endpoint definitions in clinical study design.
- Writes and reviews the statistical part of study protocols.
- Briefs CROs for appropriate conduct of statistical analysis.
- Reviews statistical analysis plans and participates in Blind Data Reviews.
- Approves database lock and requests unblinding for analysis.
- Communicates results and conclusions to ensure correct interpretation.
- Supports dossier submissions and answers statistical questions.
- Writes strategic integration plans for internal compound databases.
- Enhances knowledge of compounds through data integration and utilization activities.
- Manages external study statisticians and briefs CROs on deliverables.
- Reviews statistical literature and attends conferences for proficiency.
- Collaborates with other statisticians to acquire knowledge on new methodologies.
Key Skills:
- Expertise in statistical methodology and analysis.
- Experience in clinical trial design and protocol writing.
- Strong project management skills across therapeutic areas.
- Ability to communicate complex statistical results effectively.
- Knowledge of regulatory guidelines and compliance.
- Experience working with CROs and external study statisticians.
- Proficiency in data integration and utilization activities.
- Continuous learning and proficiency in statistical literature.
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Job responsibilities (but not limited to): Coordinates, provides, and delivers methodological and statistical expertise and/or statistical analyses. In this matter supports both the Clinical Development portfolio as well as Strategic Medical Affairs in their support to Affiliates, thereby complying with international, regulatory guidelines and policies and standards. Directs the operational aspects of statistical work as outsourced to CROs. 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 EPD, eg input into Clinical Development Plans, and 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.