Dear Allstat,
FREELANCE: Biostatistician
12 month contract
Based in Basel (100% Client site)
Excellent hourly rate
Job Description:
- Informs and suggests solutions to the project statistician on critical issues within trial.
- Makes sure that the statistical part of the protocol, the statistical analysis plan and the study reports are reviewed and approved by the project statistician
- Discusses protocol and CRF and data transfer specifications with the authors.
- Writes 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.
- Plans details of the randomization schedule with the appropriate members of the clinical trial team.
- Approves the randomization list.
- Verifies the consistency of the protocol with the CRF/data transfer specifications.
- Ensures 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.
- Discusses, reviews and approves protocol amendments
- Verifies the appropriateness of the planned analysis and writes the statistical analysis plan. Authorizes the closure/freezing of the databases and release of the randomization list.
- Assesses the impact of subjects withdrawn/lost to follow-up and of the deviations from planned trial design.
- Assesses the impact of deviations from distribution assumptions, lack of homogeneity of treatment arms, possible outliers etc.
- Documents methods and procedures used in the analysis.
- Plans and directs or performs the programming for the protocol specific data reports and statistical evaluations. Assists in programming and/or validation where appropriate.
- Discusses and plans model reports, data presentation/statistical evaluation methods and writing responsibilities with the appropriate members of the clinical study team.
- Writes the statistical section of reports (CSR, integrated safety/efficacy reports and publications). Reviews and approves the reports.
- Verifies adherence to statistical standards and SOPs/PSPs within the study.
For a confidential consultation call Laura Christie on +44 207 633 4825 or email your CV to [log in to unmask]<mailto:[log in to unmask]>
I look forward to hearing from you.
Kind regards,
Laura
Laura Christie
Principal Consultant, Biometrics, Europe
Recruiting experts in Pharma
HAYS Recruiting experts worldwide
25-27 Wootton Street
London
SE1 8TG
T: +44 207 633 4825
M: +44 7900 932031
F: +44 207 922 7101
E: [log in to unmask]<mailto:[log in to unmask]>
hayspharma.com
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