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)