Senior Biostatistician

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
  
• 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
  
• Strong analytical, problem-solving, and communication skills