Job Description

Senior Statistician - 6574 ASH
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.
Main Responsibilities:

• 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.

• 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