Clinical Data Science Programmer
Location: Bengaluru / Chennai / Trivandrum, India
Work Model: Office-Based with Flexibility (Hybrid)
Employment Type: Full-Time
Company: ICON plc
Job Summary
The Clinical Data Science Programmer is responsible for developing, validating, and maintaining programming solutions that support clinical trial data management, statistical analysis, and regulatory reporting activities. The role involves collaborating with Data Scientists, Biostatisticians, Clinical Data Managers, and Clinical Operations teams to ensure high-quality, compliant, and efficient data processing throughout the clinical development lifecycle.
The incumbent will contribute to the design, implementation, and validation of clinical data programming deliverables, ensuring adherence to industry standards, regulatory requirements, and organizational best practices.
Key Responsibilities
Clinical Data Programming
Develop, validate, and maintain programming code to support clinical trial data analysis and reporting.
Create automated solutions for data extraction, transformation, validation, and reporting.
Design and implement programming deliverables according to study requirements and project timelines.
Ensure accuracy, consistency, and quality of programming outputs.
Statistical Programming Support
Collaborate with Biostatisticians and Data Scientists to understand analytical and reporting requirements.
Develop programs to generate:
Analysis datasets
Data listings
Tables
Figures
Clinical reports
Support statistical analysis activities across clinical development programs.
Participate in the review and validation of statistical outputs.
Clinical Data Management Support
Assist in data cleaning and quality review activities.
Support data reconciliation and discrepancy management processes.
Develop validation checks and edit checks to ensure data integrity.
Work with Clinical Data Management teams to resolve data-related issues.
Programming Validation & Quality Control
Perform code review and validation activities.
Conduct testing and verification of programming outputs.
Ensure programming deliverables meet study specifications and quality standards.
Identify and resolve programming issues efficiently.
Documentation & Compliance
Maintain complete and accurate programming documentation.
Create and update:
Programming specifications
Validation documents
Standard operating procedures
Technical documentation
Ensure compliance with:
ICH Guidelines
GCP Standards
Regulatory Requirements
Company SOPs
Cross-Functional Collaboration
Work closely with:
Clinical Data Scientists
Biostatisticians
Clinical Data Managers
Clinical Operations Teams
Regulatory Affairs Teams
Medical Writing Teams
Sponsors and Study Teams
Participate in project meetings and provide programming expertise.
Support study teams in achieving project milestones and deliverables.
Data Integrity & Regulatory Compliance
Ensure integrity, traceability, and reliability of clinical trial data.
Follow industry best practices for clinical data programming.
Support audit and inspection readiness activities.
Assist with regulatory submission deliverables as required.
Continuous Improvement
Contribute to process improvement initiatives.
Develop reusable programming tools and utilities.
Support implementation of programming standards and automation strategies.
Stay updated on emerging technologies and industry trends in clinical data science.
Educational Qualifications
Required
Bachelor’s Degree in:
Computer Science
Statistics
Mathematics
Life Sciences
Biotechnology
Data Science
Information Technology
Related Scientific or Technical Discipline
Preferred
Master’s Degree in Statistics, Biostatistics, Computer Science, Data Science, or related field.
Experience Requirements
Required
Experience in programming within a clinical research, pharmaceutical, biotechnology, or healthcare environment.
Experience working with clinical trial data.
Preferred
Experience supporting clinical studies and regulatory submissions.
Experience working in CROs or pharmaceutical organizations.
Exposure to statistical programming and clinical data management processes.
Uttar Pradesh :
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Remote, India | Siliguri |Illinois :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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