Senior Statistical Data Scientist
Company: Pfizer
Location: Chennai, India (Hybrid/Flexible)
Department: Medical / Biometrics / Statistical Programming
Job Type: Full-Time
Experience: 3+ Years
JOB OVERVIEW
The Senior Statistical Data Scientist is responsible for developing high-quality statistical programming deliverables that support clinical trials, regulatory submissions, and clinical study reports. The role involves programming analysis-ready datasets, generating tables, listings, and figures (TLFs), ensuring compliance with regulatory standards, maintaining programming quality, collaborating with statisticians, and supporting study teams throughout the clinical development lifecycle.
KEY RESPONSIBILITIES
Statistical Programming
Develop and maintain SAS programs for clinical studies.
Generate analysis-ready datasets.
Program Tables, Listings, and Figures (TLFs).
Support statistical analyses for clinical trials.
Deliver programming outputs within project timelines.
Clinical Data Programming
Create SDTM and ADaM datasets.
Transform raw clinical data into analysis datasets.
Validate programmed datasets.
Ensure consistency across clinical data deliverables.
Support integrated analyses across studies.
Analysis & Reporting
Produce outputs for Clinical Study Reports (CSRs).
Generate statistical reports and summaries.
Support regulatory submission deliverables.
Prepare asset-level programming outputs.
Maintain programming documentation.
Quality Control
Perform programming quality checks.
Conduct validation and QC of datasets and TLFs.
Review programming deliverables for accuracy.
Ensure compliance with internal programming standards.
Maintain audit-ready documentation.
Clinical Trial Support
Collaborate with statisticians and programming leads.
Interpret statistical analysis specifications.
Support study startup, conduct, and closeout activities.
Resolve programming issues during study execution.
Regulatory Compliance
Follow ICH guidelines.
Ensure compliance with regulatory standards.
Apply clinical data standards.
Maintain regulatory documentation.
Support inspection readiness.
Standards & Documentation
Follow therapeutic area (TA) standards.
Contribute to programming standards development.
Maintain programming specifications.
Document programming methodologies.
Ensure version control of deliverables.
Problem Solving
Troubleshoot programming issues.
Resolve data inconsistencies.
Optimize programming efficiency.
Support process improvements.
Escalate complex issues when necessary.
Cross-Functional Collaboration
Work closely with Biostatisticians.
Collaborate with Clinical Data Management teams.
Coordinate with Statistical Programming Leads.
Support multidisciplinary project teams.
Continuous Improvement
Participate in departmental initiatives.
Improve programming workflows.
Share programming best practices.
Support innovation and automation efforts.
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Statistics
Biological Sciences
Information Technology
Computer Science
Mathematics
Related Discipline
Preferred
Master's Degree in Statistics or related field.
EXPERIENCE REQUIREMENTS
Required
Minimum 3 years of experience in:
Statistical Programming
Clinical Trials
Pharmaceutical Industry
Biotechnology
CRO
Regulatory Agency
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