Senior Documentation Lead
India
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Job Description
Senior Documentation Lead
Hyderabad, Telangana

Job Summary

  • Create Statistical Analysis Plan
  • Good 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

Biostatistics

Other Requirements

null
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Information at a Glance

Why HCLTech?

At HCLTech, you'll supercharge your potential. You'll find your career. And you'll find your spark. All at a place that knows that helping its customers stay on top starts by putting its people first.

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2026 totaled $14.8 billion.