Job Description

Job Title: Senior Statistician (AGM)
Reporting to: Senior Director Statistics
Cost Center
Responsibility (Yes)
X (No)Primary Job Function:
Coordinates, provides and delivers methodological and statistical expertise and/or statistical analyses in Clinical
Operations. In this matter supports both the Clinical Science / Operations Development portfolio as well as Strategic
Medical Affairs in their support to Affiliates, thereby complying with international, regulatory guidelines and Biometrics
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 Clinical Science, eg input into Clinical
Development Plans, and medical affairs or Affiliate 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 Clinical Operations 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 information request from health authorities related to the file. This task includes
the outline of an analysis, programming and writing the responses.
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 clinical trial data. Briefs CROs 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.
Supervisory/Management Responsibilities:
Direct Reports: - Indirect Reports: -
Position Accountability/Scope:
• Accountable for statistical design (including sample size justification), analysis and reporting of Clinical Operations
studies
• Accountable for statistical review of Affiliate study protocols
• Accountable for providing statistical support for development and/or ITB strategies
Minimum Education:
MSc. / PhD in Statistics, or Biostatistics, or a related field. Minimum Experience/Training Required:
Demonstrated competence in experimental design and statistical inference. Thorough understanding of International
Conference on Harmonization (ICH) Guideline and relevant regulatory requirements. Minimum 10 years experience as
Statistician in pharmaceutical industry or CRO. This experience should include at least one successful completion of a drug
approval at FDA or EMA.
Able to "explain" statistics to non-statisticians but also to defend statistical cases (e.g., study design features). The
incumbent is a team worker, driving for quality, and pro-active, but also insistent on statistical issues.
Works collaboratively with function management and multiple stakeholders to develop strategies for addressing
issues/requirements that arise in clinical development and marketed products support.