Project Role: Senior Clinical Database Programmer- Python/R
Work Experience:8+ Years
Work location: Bengaluru/ Any IQVIA Location in India
Work Mode: Hybrid
Must Have Skills: Python/R
Job Roles & Responsibilities:
Role Summary
The (Senior Python & R) is a senior technical individual contributor responsible for endtoend ownership of clinical data programming solutions across complex and/or multiple clinical studies.
This role serves as a technical authority within Clinical Data Management, leading advanced Python and Rbased data transformation, data review, analytics, and automation activities while ensuring compliance with clinical standards, regulatory requirements, and inspection readiness throughout the study lifecycle.
Key Responsibilities
Clinical Data Programming Leadership
- Lead the design, development, and maintenance of advanced Python and R programs to support:
- Clinical data cleaning and transformation
- Data review, metrics, and analysis
- Studylevel and programlevel reporting
- Provide technical ownership of downstream CDM programming deliverables as defined in the Data Management Plan (DMP)
- Translate protocol and DMP requirements into scalable, compliant programming solutions
StudyLevel Data Review & Quality Oversight
- Provide seniorlevel oversight of:
- Ongoing clinical data review and reconciliation
- Data trend analysis and issue identification
- Interim and final database lock readiness
- Proactively identify systemic data quality risks and drive mitigation strategies
- Ensure programming outputs are accurate, traceable, auditready, and inspectionready
Standards, Compliance & Governance
- Act as a subjectmatter expert in the application of CDISC standards (SDTM) for clinical data review and transformation
- Ensure compliance with:
- ICHGCP
- 21 CFR Part 11
- IQVIA SOPs and validation standards
- Review and approve programming documentation, specifications, and outputs as required
CrossFunctional & Sponsor Engagement
- Serve as a senior technical interface with:
- Data Management Leads
- Clinical Programmers
- Statistical Programming
- Medical Review teams
- Sponsor stakeholders
- Provide expert input into studylevel discussions related to data review strategy, timelines, and risks
- Support sponsor audits, inspections, and technical discussions
Automation, Innovation & Standardization
- Architect and implement reusable Python/R frameworks, libraries, and utilities
- Lead or contribute to automation initiatives to reduce manual data review and improve efficiency
- Drive standardization and bestpractice initiatives within CDM programming
- Provide technical mentorship and guidance to Grade 130/140 programmers
Required Skills & Qualifications
Technical Skills (Mandatory)
- Expertlevel handson experience in Python and R Programming
- Advanced proficiency with:
- Python: Pandas, NumPy (PySpark exposure preferred)
- R for statistical analysis and complex data exploration
- Strong SQL and data manipulation skills
- Extensive experience working with clinical trial data
- Strong applied knowledge of CDISC / SDTM
- Proven experience working in regulated clinical data environments
Systems & Tools
- Experience with EDC / CDB / CDMS platforms
- Data review, reconciliation, and reporting tools
- Version control systems (e.g., Git)
- Experience supporting large, complex, or global clinical studies
Education
- Bachelor's or Master's degree in:
- Computer Science
- Statistics
- Data Science
- Life Sciences
- Engineering
- (or equivalent practical experience)
