Anna Nagar Chennai Tamil Nadu Biostatistician Jobs – 2 Open Jobs Today

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SRM Technologies —Chennai, Tamil Nadu
- Full-time
- Master's degree
- Analysis skills
- Bachelor's degree
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Senior Biostatistician

SRM Technologies -
Chennai, Tamil Nadu

Apply Now

Job details

Full-time

Qualifications

Statistics
Clinical research
Statistics
XML
SAS
SAP
R
Master's degree
Statistical analysis
Analysis skills
Quality assurance
Bachelor's degree
Macros
Clinical trials
Communication skills
Python
FDA regulations

Full job description

Job Information

Date Opened 08/14/2026
Job Type Full time
City Chennai
State/Province Tamil Nadu
Country India
Zip/Postal Code 600096
Industry Health Care

Job Description

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

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