Senior Clinical Data Science Programmer (Rave + Custom Functions)
Location: Chennai, India | Bangalore, India
Work Model: Office with Flex
Employment Type: Full-Time
Job ID: JR142814
Company: ICON plc
ThePharmaDaily.com is featuring an opportunity for a Senior Clinical Data Science Programmer with ICON plc, a global clinical research organization delivering data-driven solutions across clinical development programs. This role is designed for experienced clinical data programmers with strong expertise in Medidata Rave, custom functions, and CDISC-compliant clinical datasets.
Experience Required
Minimum 4+ years of experience in clinical data programming within the pharmaceutical, biotechnology, or CRO industry, with hands-on experience in Rave and Custom Function development.
Job Overview
The Senior Clinical Data Science Programmer plays a critical role in designing, developing, and validating clinical data programming solutions that support global clinical trials. The role focuses on efficient data handling, analysis-ready dataset preparation, and generation of tables, listings, and figures (TLFs) aligned with regulatory standards.
This position requires strong technical expertise in electronic data capture (EDC) systems, particularly Medidata Rave, along with in-depth knowledge of CDISC standards (SDTM and ADaM). The successful candidate will collaborate with cross-functional teams including Biostatistics, Data Management, and Clinical Operations to ensure high-quality, submission-ready outputs.
Key Responsibilities
Lead the design, development, and validation of clinical data science programming solutions
Develop and implement Medidata Rave custom functions and edit checks
Program and validate datasets, tables, listings, and figures (TLFs) as per study requirements
Ensure compliance with CDISC standards including SDTM and ADaM
Perform rigorous quality control (QC) and validation checks to ensure data integrity and accuracy
Collaborate with biostatisticians, data managers, and clinical teams to define data specifications and analysis plans
Support regulatory submission activities with submission-ready datasets and documentation
Mentor junior programmers and provide technical leadership within the data programming team
Manage multiple projects while maintaining timelines and quality standards
Required Qualifications
Bachelor’s or advanced degree in Computer Science, Biostatistics, Data Science, Life Sciences, or related discipline
4+ years of experience in clinical data programming
Strong proficiency in Medidata Rave and Custom Function development
In-depth knowledge of CDISC standards (SDTM, ADaM) and clinical trial data structures
Experience generating and validating TLFs for clinical studies
Strong understanding of regulatory requirements and ICH-GCP guidelines
Excellent analytical and problem-solving skills
Strong communication and leadership capabilities
Core Competencies
Clinical data programming
Medidata Rave and custom function development
CDISC (SDTM and ADaM) compliance
TLF programming and validation
Regulatory submission support
Data quality control and validation
Cross-functional clinical collaboration
Compensation and Benefits
ICON offers a competitive salary package aligned with industry standards. Country-specific benefits are designed to support employee well-being, financial planning, and work-life balance. Benefits may include:
Annual leave entitlements
Comprehensive health insurance coverage
Retirement and savings programs
Life assurance
Global Employee Assistance Programme (TELUS Health)
Flexible optional benefits such as wellness programs, childcare support, gym memberships, and travel subsidies
Equal Opportunity Statement
ICON is committed to fostering an inclusive and accessible workplace. All qualified applicants will receive equal consideration regardless of race, religion, gender, disability, veteran status, or other protected characteristics. Reasonable accommodations are available during the recruitment and employment process.
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