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.

  

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.

  

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

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