Job Descriptions - R&D; Clinical Roles
1. BIOSTATISTICIAN
Position: Senior Associate - Bio statistician
Department: R&D; Clinical
Location: Chennai, India
Number of Positions: 1
Role Overview
Provides statistical expertise for clinical trial design, analysis, and reporting, ensuring scientifically sound and regulatory-compliant statistical methodologies.
Key Responsibilities
Develop Statistical Analysis Plans (SAP) for clinical studies
Design randomization schemes and perform sample size calculations
Review and provide statistical input for clinical protocols and amendments
Create and review Tables, Listings, and Figures (TLFs)
Write and review Clinical Study Reports (CSR) statistics sections
Develop SDTM and ADaM datasets following CDISC standards
Program statistical analyses using SAS, including macros development
Perform validation programming for quality assurance
Generate define.xml files for regulatory submissions
Ensure CDISC compliance across all deliverables
Collaborate with cross-functional teams (clinical, data management, regulatory)




Design and develop operational dashboards for real-time study monitoring
Create KPI reports for enrollment tracking, site performance, and data quality metrics
Perform advanced statistical analysis using SAS, Python, and R
Develop interactive data visualizations using Spotfire
Conduct safety reporting analytics and signal detection
Generate ad-hoc analytical reports for management and stakeholders
Implement automated reporting solutions to improve efficiency
Monitor data quality and identify trends or anomalies
Support risk-based monitoring (RBM) initiatives through analytics
Present analytical findings to cross-functional teams

Required Qualifications
Bachelor's/Master's in Statistics, Biostatistics, Mathematics, or related field
8-10 years of experience in pharmaceutical/clinical research biostatistics
Required Certification: SAS Certified Base Programmer or Advanced Programmer
Robust knowledge of statistical methodologies

📌 Senior Biostatistician (Chennai)
🏢 SRM Technologies
📍 Chennai