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Job Descriptions - RD Clinical Roles

1. BIOSTATISTICIAN

Position: Senior Associate - Bio statistician
Department: RD 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
- Bachelors/Masters in Statistics, Biostatistics, Mathematics, or related fiel

📌 Senior Biostatistician Professional (Chennai)
🏢 SRM Technologies
📍 Chennai