Role & responsibilities

Write Statistical Analysis Plans (SAPs) independently for clinical studies

- Perform randomisation schedule generation and sample size calculations at the protocol design

stage
- Conduct statistical analysis in line with CDSCO and international guidance
- Prepare statistical tables, listings, and figures (TLFs) for study reports and regulatory submissions
- Provide statistical input during protocol development and study design discussions
- Support Data Management on dataset structure and analysis-readiness requirements
- Write Statistical Analysis Plans (SAPs) independently for clinical studies sponsors

Preferred candidate profile Master's degree in Biostatistics, Statistics, or a related quantitative field

- 3-4 years of relevant biostatistics experience in a CRO or pharmaceutical company, or solid

academic project work in clinical biostatistics with demonstrable independent capability
- Working knowledge of SAS and/or R, with practical experience generating TLFs
- Understanding of regulatory statistical requirements under CDSCO

📌 Bio Statistician (Manesar)
🏢 Auriga Research Private
📍 Manesar