Biostatistician

HCLTech; Hyderabad; On-site; INR 1,400,000 - 2,000,000; Full time

Job summary

HCLTech is seeking a Statistics Lead to author and provide input on statistical sections of clinical study documents, including protocols, SAPs, TLF shells, and SDTM/ADaM specifications.

The role drives TLF development with programming teams, determines analysis populations, validates results, and presents findings to key stakeholders. A Master’s in statistics and 5+ years in pharma/clinical research with SAS/R/SPSS/Python proficiency is required.

Qualifications

• Master's degree in Statistics, Biostatistics, Mathematics, or related field.
• 5+ years of experience in a similar pharmaceutical/clinical research role.
• Proficiency in SAS, R, SPSS and Python; strong data processing skills; domain knowledge in clinical research.

Responsibilities

• Author and/or provide input on statistical sections of clinical study documents (protocols, SAPs, TLF shells, SDTM/ADaM specs).
• Drive TLF development and reviews with programming and team members, determine analysis populations, validate results, present findings.
• Calculate sample sizes as requested.
• Represent the Statistics function in study team meetings.

Skills

Statistical analysis

Study team communication

Data interpretation

Education

Master's degree in Statistics/Biostatistics/Mathematics

Tools

SAS

R

SPSS

Python

Job description

• 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

Essential Qualifications:

• 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