Senior Statistician (6574)

CTC Resourcing Solutions; Basel; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

An innovative bio-pharmaceutical company in Switzerland is seeking a Senior Statistician for a contract role based in Basel. The role involves overseeing biostatistical elements in clinical studies, planning analyses, and ensuring adherence to statistical standards. Candidates must have a strong background in statistics related to clinical trials along with relevant experience in the pharmaceutical industry.

Qualifikationen

• Minimum five years' experience as a statistician in clinical development.
• In-depth knowledge of statistics and applications in clinical trials.
• Fluency in English required.

Aufgaben

• Responsible for biostatistical aspects of clinical projects.
• Plans randomization schedules and reviews clinical trial protocols.
• Writes statistical analysis plans and reports.

Kenntnisse

Statistical analysis

Interpersonal skills

Communication skills

Ausbildung

University degree in mathematics, statistics or related disciplines

Tools

SAS

Jobbeschreibung

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 aSenior Statisticianfor a contract role based inBasel.

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