Senior Statistician

Tasks

- Responsible for all biostatistical aspects of the assigned project and/or trial
- Interact with authorities statisticians to set and or defend decisions on statistical issues for the assigned project
- Plan details of the randomization schedule with the project team
- Review and approve protocol and CRF (and their amendments) prior to their use or submission to approval committees
- Verify the appropriateness of the planned analysis and write or superve the writing of the trial statistical analysis plan
- Perform or supervise statistical analyses as well as discussing and presenting the results with team members
- Write or support the writing of the statistical section/module of reports (CSR, integrated safety/efficacy reports and publications) and review and approve the reports
- Verify adherence to statistical standards and SOPs within the project
- Ensure appropriate statistical planning, analysis and reporting of one or more assigned clinical studies, development programs or drug submission dossier
- Review and anticipate resource requirements for existing projects
- Maintain / develop a high standard of statistical methodology

Qualifications

- University degree (or equivalent) in mathematics, statistics or related discipline
- In depth knowledge and expertise in statistics and its applications to clinical trials
- Good knowledge of statistical software (at least SAS®) and of data management principles and tools.
- At least five years experience as statistician in clinical development in the pharmaceutical industry or in clinical research institutions
- Knowledge of international clinical research regulations and requirements.
- Ability to work efficiently in an international team environment
- Excellent interpersonal, communication and management / coaching skills
- Must be able to work to schedules and meet project deadlines
- Fluent in English