- Review clinical trials protocols
- Manage clinical trials statistical analysis: create a plan of statistical analysis, program it in SAS and make quality control
- Organize the commitée of data reviews before freezing of the base
- Participate in the communication with the regulatory authorities (ANSM, FDA, EMA) from the point of protocol redaction till its registration
- Validate the development and assure the supervision of the randomization tools (IVRS and IWRS), train the team
Awareness of statistical analysis plan (SAP) with application to Survival analysis, Adaptive trial design, Multiplicity adjustment, and Missing data imputation.
· Three years industry experience of comparative oncology and any chronic therapeutic area phase 2 and 3 efficacy and safety data handling in SAS software.
· Person should be MS (Statistics) or higher from reputed institution/university.