Life Science : Trial Statistician

Job Description

• Develop documents e.g.
  • Clinical Trial Protocol (CTP),
  • Trial Statistical Analysis Plan (TSAP),
  • 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)
  • Review the data management plan (DMP) and data collection specifications distributed by TDM
  • Support treatment assignment in SDTM
  • 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.)