Jenni Woolley is recruiting for a Statistician to join a company in the Pharmaceutical and Bio-technology industry at their site based in Basel, Switzerland on a one year contract.
The main purposes of the role will be to:
-Write the statistical section of the protocol stating the hypothesis, defining the planned analysis, primary and secondary variables, time periods, interim analysis specifications, intent-to-treat population and explaining the statistical basis for the choice of sample size.
-Plan details of the randomization schedule with the appropriate members of the clinical trial team.
-Discuss protocol and CRF with the clinical trial team.
-Verify the consistency of the protocol with the CRF.
-Review protocol and CRF prior to their use or submission to approval committees.
-Verify the appropriateness of the planned analysis and writes the trial analysis plan.
Further responsibilities will include:
-Documenting methods and procedures used in the analysis.
-Where appropriate, planning and directing, performing, or assisting in the programming and/or validation of protocol specific data reports and statistical evaluations.
-Performing standard and special analyses and discusses the results and the presentation of the results with appropriate team members.
-Ensuring that all statistical deliverables are verified and provided to the appropriate clinical team members
-Writing or supporting the writing of the statistical section/module of reports (FSR, integrated safety/efficacy reports and publications).
-Maintaining up-to-date project and trial documentation including that of presentation and analyses.
-Verifying adherence to statistical standards and SOPs within the project or trial.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
-University degree (or equivalent) in mathematics, statistics or related disciplines.
-Good knowledge of statistical software (at least SAS®) and of data management principles and tools.
-Experience as statistician in clinical development in pharmaceutical industry or clinical research organizations.
-Knowledge of international clinical research regulations and requirements.
-Ability to work efficiently in an international team environment.
-Must be able to work according to timelines and achieve deadlines.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL40373 in all correspondence.
You MUST be eligible to work in Switzerland. Learn more
- Agency: CK Group (Science, Clinical, Engineers and IT Recruitment)
- Posted: 13th October 2017
- Expires: 10th November 2017
- Reference: CL40373