Hyderabad, Telangana
Job Summary
Create Statistical Analysis Plan
Positive understanding on ICH GCP and other pertinent regulations
Provide inputs to Clinical Study Report
Key Responsibilities
1
Author and/or provide input on statistical sections of clinical study documents including protocols, electronic case report forms, randomization plans, data transfer specifications, statistical analysis plans, tables, listings, and figures (TLF) shells, SDTM/ADaM specifications, clinical study reports, and other relevant documents.
Drive TLF development and TLF reviews with programming and other relevant team members, determine analysis populations, validate key analysis results, and present final analysis results to key stakeholders
Calculate sample sizes, as requested
Represent the Statistics function in study team meetings
Skill Requirements