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SENIOR STATISTICIAN – 4892
Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking a Senior Statistician for a permanent role based in Basel area.
The ideal candidate should have atleast 5 years of experience in clinical development and be responsible for all the biostatistical aspects of the study.
- Responsible for all biostatistical aspects of the project and/or trial, the statistician is assigned to.
- Interacts with authorities statisticians to set and/or defend decisions on statistical issues for the project, the statistician is assigned to.
- Plans details of the randomization schedule with the appropriate members of the project team.
- Reviews and approves protocol and CRF (and their amendments) prior to their use or submission to approval committees.
- Verifies the appropriateness of the planned analysis and writes or supervises the writing of the trial statistical analysis plan.
- Performs or supervises statistical analyses and discusses the results and the presentation of the results with appropriate team members.
- Writes or supports the writing of the statistical section/module of reports (CSR, integrated safety/efficacy reports and publications). Reviews and approves the reports.
- Verifies adherence to statistical standards and SOPs within the project.
- Ensures appropriate statistical planning, analysis and reporting of one or more assigned clinical studies, development programs or drug submission dossier.
- Reviews and anticipates resource requirements for existing projects.
- Maintains / develops a high standard of statistical methodology.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- University degree (or equivalent) in mathematics, statistics or related disciplines.
- 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 within the pharmaceutical industry or clinical research organizations.
- 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 according to timelines and achieve project deadlines.
- Fluent in English.