Hyderabad, Telangana
Job Summary
Create Statistical Analysis Plan
Valuable understanding on ICH GCP and other pertinent regulations
Provide inputs to Clinical Study Report
Key Responsibilities
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
Education: Minimum of a Master's degree in Statistics, Biostatistics,



Mathematics, or a related discipline.
5+ years of experience in similar role in the pharmaceutical or clinical research industry.
Technical Skills: Proficiency in programming and data processing (SAS, R, SPSS, Python).
Domain Knowledge: Understanding of clinical research, epidemiology, and biological data standards
Other Requirements
Create Statistical Analysis Plan
Good understanding on ICH GCP and other pertinent regulations
Provide inputs to Clinical Study Report
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📌 Documentation Manager (Hyderabad)
🏢 HCLTech
📍 Hyderabad