Senior Statistician
Idorsia
Basel, CH
vor 19 Std.

Job 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.
  • Candidate’s Requirements

  • 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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