Senior Statistician (5237)
Senior Statistician – 5237 URA
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 contract role based in Basel.
• 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 Swiss working/residency permit and/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