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
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Develop Statistical Analysis Plans (SAP) for clinical studies
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Design randomization schemes and perform sample size calculations
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Review and provide statistical input for clinical protocols and amendments
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Create and review Tables, Listings, and Figures (TLFs)
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Write and review Clinical Study Reports (CSR) statistics sections
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Develop SDTM and ADaM datasets following CDISC standards
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Program statistical analyses using SAS, including macros development
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Perform validation programming for quality assurance
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Generate define.xml files for regulatory submissions
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Ensure CDISC compliance across all deliverables
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Collaborate with cross-functional teams (clinical, data management, regulatory)
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Design and develop operational dashboards for real-time study monitoring
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Create KPI reports for enrollment tracking, site performance, and data quality metrics
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Perform advanced statistical analysis using SAS, Python, and R
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Develop interactive data visualizations using Spotfire
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Conduct safety reporting analytics and signal detection
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Generate ad-hoc analytical reports for management and stakeholders
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Implement automated reporting solutions to improve efficiency
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Monitor data quality and identify trends or anomalies
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Support risk-based monitoring (RBM) initiatives through analytics
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Present analytical findings to cross-functional teams
Required Qualifications
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Bachelor's/Master's in Statistics, Biostatistics, Mathematics, or related field
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8-10 years of experience in pharmaceutical/clinical research biostatistics
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Required Certification: SAS Certified Base Programmer or Advanced Programmer
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Strong knowledge of statistical methodologies and clinical trial designs
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Thorough understanding of ICH guidelines and regulatory requirements
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Experience with FDA and EMA submission standards
Technical Skills
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Advanced SAS programming skills (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macros)
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Advanced R programming skills and Python programming skills
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Expertise in CDISC standards (SDTM, ADaM, define.xml)
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Proficiency in statistical analysis and interpretation
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Knowledge of Pinnacle 21 Community for validation
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Experience with randomization and sample size calculation tools
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Strong analytical, problem-solving, and communication skills
