Senior Clinical Database Programmer - Python & R

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 end‑to‑end 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 R–based 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
Study‑level and program‑level 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
Study‑Level Data Review & Quality Oversight
Provide senior‑level 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, audit‑ready, and inspection‑ready
Standards, Compliance & Governance
Act as a subject‑matter expert in the application of CDISC standards (SDTM) for clinical data review and transformation
Ensure compliance with:
ICH‑GCP
21 CFR Part 11
IQVIA SOPs and validation standards
Review and approve programming documentation, specifications, and outputs as required
Cross‑Functional & 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 study‑level 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 best‑practice initiatives within CDM programming
Provide technical mentorship and guidance to Grade 130/140 programmers
Required Skills & Qualifications
Technical Skills (Mandatory)
Expert‑level hands‑on 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)