Senior Biostatistician Professional

SRM Technologies; Chennai District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

SRM Technologies in Chennai, India seeks a Senior Associate - Biostatistician to provide statistical expertise for clinical trial design, analysis, and reporting.

You will develop SAPs, SDTM/ADaM datasets, write CSR statistics sections, and ensure CDISC compliance while collaborating with cross-functional teams. Experience with SAS, R, Python and data visualization tools like Spotfire is expected.

Qualifications

• Bachelor’s or higher degree in statistics/biostatistics or related field.
• 8–10 years in pharmaceutical/clinical research biostatistics.
• SAS Base Programmer or Advanced Programmer certification.
• Strong knowledge of trial design and regulatory guidelines.

Responsibilities

• Develop SAPs for clinical studies and randomization schemes.
• Create and validate TLFs and CSR statistics sections.
• Develop SDTM/ADaM datasets per CDISC standards.
• Program analyses using SAS and SAS Macros; validate outputs.
• Generate define.xml and ensure regulatory submissions readiness.
• Collaborate with cross-functional teams (clinical, data management, regulatory).
• Develop dashboards and KPI reports for study monitoring.

Skills

Biostatistics

Statistical analysis

SAS programming

R programming

Python programming

SAS Macros

CDISC standards

Education

Master's degree in Biostatistics or Statistics

Bachelor's degree in related field

Tools

SAS

SAS/STAT

SAS Macros

R

Python

Spotfire

CDISC Define.xml

Job description

Job Descriptions - RD Clinical Roles

1. BIOSTATISTICIAN

Position: Senior Associate - Bio statistician

Department: RD 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

• Bachelors/Masters 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)