Senior Biostatistician Professional
SRM Technologies Pvt.Ltd · Chennai · onsite · Posted 66d ago
Undisclosed8–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
[{"Remote_Job":false , "Posting_Title":"Senior Biostatistician" , "Is_Locked":false , "City":"Chennai" , "Industry":"Health Care","Job_Description":"
Job Descriptions - RD Clinical Roles
1. BIOSTATISTICIAN
Position: Senior Associate - Bio statistician
Department: RD Clinical
Location: Chennai, India
Number of Positions: 1
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)
- Advanced SAS programming skills (Base SAS, SAS/STAT, SAS/GRAPH, SAS Macros)
- Bachelors/Masters in Statistics, Biostatistics, Mathematics, or related field
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
SAPclinical data managementclinical researchManager Quality AssuranceAnalyticsSASMacrosXMLoperationsanalytical
About SRM Technologies Pvt.Ltd
SRM Technologies Pvt.Ltd
IT Services & Consulting
1.2k+
employees
1998
28 years old
Chennai, Tamil Nadu
IN
₹6.3L PA avg
Avg at SRM Technologies Pvt.Ltd
About
A leading IT services partner continuously looking for great talent. The company is backed by SRM Group, a billion-dollar conglomerate in India.
Industries
IT Services & ConsultingEmerging TechnologiesIndustrial Automation
Employee ratings
10 reviews
3.5/ 5
Culture
3.2
Career growth
2.4
Work-life
3.1
Employees rate it well for
Job Security36Overall Company35
Find them on