Job Descriptions - R&D; Clinical Roles

- 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

- Strong knowledge of statistical methodologies and clinical trial designs

- Thorough understanding of ICH guidelines and regulatory requirements

- Experience with FDA and EMA submission standards

Technical Skills

- Advanced SAS programming skills (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macros)

- Advanced R programming skills and Python programming skills

- Expertise in CDISC standards (SDTM, ADaM, define.xml)

- Proficiency in statistical analysis and interpretation

- Knowledge of Pinnacle 21 Community for validation

- Experience with randomization and sample size calculation tools

- Solid analytical, problem-solving, and communication skills

📌 Senior Biostatistician (Chennai)
🏢 SRM Technologies
📍 Chennai