Provide statistical expertise for clinical trial design, analysis, and reporting. Develop SAPs, randomization schemes, TLFs, SDTM/ADaM datasets, and define.xml. Program and validate analyses in SAS, R, and Python; create dashboards, Spotfire visualizations, and automated reports. Ensure CDISC/ICH compliance, support regulatory submissions, safety analytics, RBM, and present findings cross-functionally.
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
SRM Technologies Chennai, Tamil Nadu, IND Office
Chennai, India
SRM Technologies Chennai, Tamil Nadu, IND Office
Perungudi, Campus 1A, 5th Floor, RMZ Millenia Business Park, , , , Chennai, Tamil Nadu, India, 600096
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