Profile:
Rolling contract opportunity in Switzerland, with a clinical trials company, where you will be responsible for all biostatistical aspects of the study and inform and suggests solution to the project statistician on critical issues within trial.
In this role, you will ensure that the statistical part of the protocol, the statistical analysis plan and the study reports are reviewed and approved by the project statistician and discuss protocol and CRF and data transfer specifications with the authors.
You will 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.
Your other responsibilities include:
Planning details of the randomization schedule with the appropriate members of the clinical trial team.
Approving the randomization list.
Verifying the consistency of the protocol with the CRF/data transfer specifications.
Ensuring that the trial design is compatible with the trial objectives.
Reviews and approves protocol and CRF/data transfer specifications prior to their use or submission to approval committees.
Educational background and experience: MSc in Medical Statistics or equivalent and several years experience working in a CRO, pharmaceutical or biotechnology company. Must be eligible to work in the EEA and have excellent written and spoken English.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the country where the job is based. Carlisle Staffing plc, trading as SRG is an Employment Business/Agency.
| Consultant: |
Helena Newman-Mitchell |
