Senior Biostatistician

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

Job summary

SRM Technologies in Chennai is seeking a senior Biostatistician to provide statistical expertise for clinical trial design, analysis, and reporting, ensuring regulatory-compliant methodologies.

Role involves SAP development, CDISC SDTM/ADaM datasets, CSL/CSR statistics sections, and CDISC adherence, with cross-functional collaboration and real-time dashboards.

Qualifications

• 8-10 years in pharmaceutical/clinical research biostatistics.
• Certified SAS Base or Advanced Programmer.
• Strong knowledge of ICH guidelines and regulatory requirements.
• Experience with FDA/EMA submission standards.

Responsibilities

• Develop SAPs for clinical studies.
• Design randomization schemes and compute sample sizes.
• Review protocols and amendments for statistics.
• Create and review TLFs and CSR statistics sections.
• Develop SDTM/ADaM datasets per CDISC.
• Perform validation programming for QA.
• Generate define.xml for submissions.
• Ensure CDISC compliance across deliverables.
• Collaborate with cross-functional teams (clinical, data management, regulatory).
• Design dashboards for real-time study monitoring.
• Create KPI reports for enrollment, site performance, data quality.
• Conduct advanced analysis using SAS, Python, R.
• Develop interactive visualizations using Spotfire.
• Support risk-based monitoring analytics.
• Present findings to stakeholders.

Skills

SAS programming

R programming

Python programming

CDISC SDTM/ADaM

Define.xml

Statistical analysis

Data visualization

Clinical trial design

Regulatory submissions

SAS certification

Education

Bachelor's/Master's in Statistics/Biostatistics/Mathematics

Tools

Pinnacle 21 Community

Spotfire

Job description

SRM Technologies is a global digital and engineering partner delivering capabilities across data and AI, enterprise platforms, embedded and platform engineering, supply chain, and design-to-manufacturing services.

We work across high-impact industries such as Mobility, Life Sciences, Healthcare, and Logistics, supporting enterprises across North America, APAC, and Europe in building intelligent, future-ready ecosystems and driving transformation at scale.

As a Great Place to Work®-certified organization, we are committed to creating an environment where people can learn, grow, and thrive. We believe empowered individuals drive innovation, deliver value to customers, and play a meaningful role in shaping our collective success.

At SRM Tech, every contribution matters, and we are always looking for passionate individuals who are eager to shape their careers with us.

Preferred Experience

8-10 years

About the Role

Department: R&D Clinical

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
• 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

SRM Tech is an equal opportunity employer committed to diversity, equity, inclusion, and belonging. We make all hiring decisions based on merit, without bias or discrimination, in line with applicable laws.