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Associate Director/Expert Statistician – 4893
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 Associate Director/Expert Statistician for a permanent role based in Basel area.
The ideal candidate should have over 10 years of experience in clinical development. For this particular position, it would be of added value if the person has experience in medical affairs or marketing, that is: the broad range of statistics that is needed after a drug has been approved and has entered the market. We are looking for a statistician who is not only strong in statistics, but is also able to present the design and analysis aspects in a multidisciplinary clinical trial team.
- 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 working/residency permit or Swiss/EU-Citizenship required.
- University degree in statistics, mathematics or a related discipline
- At least 10 years of experience as statistician in clinical development within a pharmaceutical company, clinical/academic research organization or university medical statistics department.
- At least five years as Senior Statistician, (i.e., above Statistician level) in Clinical Development in the Pharmaceutical Industry, or Clinical Research Organizations.
- In depth knowledge and expertise in statistics and its applications to clinical trials
- Proven record of successfully managing external service providers
- Knowledge of international clinical research regulations and requirements
- Knowledge of statistical software (at least SAS®, preferably also R)
- Excellent interpersonal and communication skills
- Fluent in English