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