Statistical Programmer
Location: Bangalore, India
Employment Type: Full Time
Job Overview
The Statistical Programmer is responsible for providing advanced statistical programming expertise to support clinical research studies and drug development programs. The role involves developing, testing, validating, and documenting statistical programs, analysis datasets, tables, listings, and figures (TLFs) while ensuring compliance with regulatory standards and client requirements.
The position requires strong SAS programming expertise, leadership capabilities, project management skills, and the ability to support complex global clinical trials.
Key Responsibilities
Statistical Programming
Develop, test, validate, and document statistical programs for clinical studies.
Create:
Statistical Tables
Figures
Listings (TFLs)
Summary Outputs
Program analysis datasets and derived datasets in accordance with study requirements.
Support internal and external data transfer activities.
Develop and execute database quality control checks when required.
Clinical Data Integration
Program and manage integration of databases from:
Multiple Clinical Studies
External Data Sources
Vendor Data Sources
Ensure consistency, integrity, and accuracy of integrated datasets.
Support data standardization and harmonization activities.
Programming Documentation
Develop and maintain:
Programming Plans
Functional Specifications
Validation Documentation
Programming Standards
Ensure all documentation complies with regulatory and organizational requirements.
Maintain audit-ready programming records.
Technical Leadership
Provide advanced technical expertise to project teams and stakeholders.
Serve as a senior programming resource for complex studies.
Support troubleshooting and resolution of programming-related issues.
Independently propose technical solutions and process improvements.
Process Development & Innovation
Design, develop, and validate:
SAS Macros
Utilities
Automation Tools
Process Enhancements
Support implementation of new technologies and methodologies.
Contribute to departmental process improvement initiatives.
Project & Team Leadership
Function as Statistical Programming Team Lead for:
Complex Clinical Studies
Multi-study Programs
Global Projects
Coordinate programming activities across project teams.
Monitor timelines, deliverables, and resource utilization.
Ensure high-quality outputs are delivered on time and within budget.
Financial & Resource Management
Understand project scope, assumptions, and contractual requirements.
Support:
Resource Forecasting
Budget Monitoring
Effort Estimation
Out-of-Scope (OOS) Management
Provide revenue forecasts and project status updates when required.
Training & Mentorship
Provide technical guidance and mentorship to junior programmers.
Support onboarding and skill development initiatives.
Conduct knowledge-sharing and training sessions.
Promote best practices and programming standards.
Quality & Compliance
Ensure compliance with:
CDISC Standards
Regulatory Requirements
Good Clinical Practice (GCP)
Internal SOPs
Participate in audits and inspections when required.
Maintain high-quality programming deliverables and documentation.
Qualifications
Education
Master's Degree in:
Computer Science
Statistics
Mathematics
Information Technology
Related Field
AND
10 years of relevant experience
OR
Bachelor's Degree in:
Computer Science
Statistics
Mathematics
Information Technology
Related Field
AND
11 years of relevant experience
Equivalent combination of education and experience may be considered.
Experience (Minimum Required)
10+ years of Statistical Programming experience.
Experience supporting:
Clinical Trials
Drug Development Programs
Pharmaceutical or CRO Environments
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