Bio Statistician

Auriga Research; Gurugram District; Sur place; INR 900 000 - 1 300 000; Plein temps

Résumé du poste

Auriga Research Pvt. Ltd. is seeking an experienced biostatistician to independently write SAPs for clinical studies. The role involves generating randomisation schedules, computing sample sizes, and performing analyses per CDSCO and international guidelines.

The candidate will prepare TLFs for reports and regulatory submissions, contribute to protocol development, and support data management for analysis-ready datasets. Requires 3–4 years in biostatistics with SAS or R proficiency.

Qualifications

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

Responsabilités

• Write Statistical Analysis Plans (SAPs) independently for clinical studies
• Perform randomisation schedule generation and sample size calculations at the protocol design
• 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

Formation

Master's degree in Biostatistics

Outils

SAS

R

Description du poste

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 strong

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