Documentation Manager
India
Apply now
Job Description
Documentation Manager
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

  • 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
Apply now
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 226,300 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 December 2025 totaled $14.5 billion.
23 Benefits At HCLTech, we believe in empowering our employees with comprehensive benefits that support their professional growth and enhance their well-being. When you sign up for a career with us, you gain access to: https://rmkcdn.successfactors.com/147eb21f/a701dca9-f32d-4fc9-9447-6.svg Industry-benchmarked compensation https://rmkcdn.successfactors.com/147eb21f/b0c54381-ddcc-4a33-9b35-9.svg Best-in-class healthcare benefits https://rmkcdn.successfactors.com/147eb21f/b73027be-7aae-4d36-a090-4.svg Personal time off https://rmkcdn.successfactors.com/147eb21f/d5b4fdfd-2e99-4e26-9878-9.svg Maternity and paternity benefits https://rmkcdn.successfactors.com/147eb21f/3d42b0fc-4652-435a-9ece-c.svg Access to skills / higher education programs/resources https://rmkcdn.successfactors.com/147eb21f/aeddeaf2-9e25-4584-ad11-d.svg Discounts on products and services via Benefit Box https://rmkcdn.successfactors.com/147eb21f/a9609a3b-2700-4b3c-9d90-a.svg Participate in CSR programs and live life with a purpose https://rmkcdn.successfactors.com/147eb21f/c6e33851-710f-4634-bd69-f.svg Opportunities to grow and advance your career Note: The benefits listed above vary depending on the nature of your employment and the country where you work. Some benefits may be available in some countries but not in all.