Trial Statistician

Job Code # 77

Job Location-  Pan India

Salary- 10 LPA to 15 LPA

Key skills-
a) Qualification: statistical background (B.Sc. & M.Sc. Statistics)
b) Should have experience in Sample size, Biostatistician, Mock shell, Sample sizing calculation, Statistical Analysis Plan(SAP), Statistics
c) Knowledge of Clinical Trial Protocol, Clinical Trial Report

Job Description-
• Develop documents e.g.
o Clinical Trial Protocol (CTP),
o Trial Statistical Analysis Plan (TSAP),
o Randomization specifications & initiate randomization scheme creation
• Participate in the development of Integrated Quality and Risk Management (IQRM) plan and MQRP
• Support Trial Data Manager (TDM)
o Review the data management plan (DMP) and data collection specifications distributed by TDM
o Support treatment assignment in SDTM
o Provide input to and review Data Review Plan (DRP) prepared by TDM
• Participate and provide input in meetings (e.g., Trial Oversight Meeting (TOM), organized by CTL; investigators meeting Create and maintain documents in BDS TMF
• Plan, handle and communicate about trial-specific statistical topics and issues e.g., Sample Size Calculation, Statistical Analysis Strategy Organize and chair Result Planning Meeting (RPM), prepare and participate in the Result Alignment Meeting (RAM)
• Support TPROG for TSAP implementation and statistical QC of programs, Finalization of QC/Validation. Participate in preparation of Clinical Trial Report (CTR)
• Handle unexpected data after final data delivery Wrap-up TOM
• Specify non-CTR specific analyses, Planned/Ad hoc data delivery during trial conduct, e.g. interim analysis Support electronic submission
• Data delivery at final trial closure, Give input to public disclosure of clinical trial results (CT.gov, EudraCT, etc.)