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