Senior Clinical Database Programmer - Python & R

IQVIA India; Bengaluru; Hybrid; INR 1,500,000 - 2,500,000; Full time

Job summary

A leading healthcare consultancy is looking for a Senior Clinical Database Programmer with expertise in Python and R to oversee clinical data programming solutions. The role involves leading advanced programming initiatives, ensuring compliance with clinical standards, and mentoring junior team members. Ideal candidates have over 8 years of experience, strong SQL and data manipulation skills, and a deep understanding of clinical trial data systems. This position is hybrid based in Bengaluru, Karnataka.

Qualifications

• 8+ years of experience in clinical data programming with Python and R.
• Expert-level hands-on experience in data analysis and complex data exploration.
• Proven experience supporting large, complex clinical studies.

Responsibilities

• Lead design and development of clinical data programming solutions.
• Ensure compliance with regulatory requirements and high-quality standards.
• Mentor junior programmers and drive best practice initiatives.

Skills

Python

R

SQL

Data manipulation

CDISC standards

Data review

Tools

EDC / CDB / CDMS platforms

Version control systems (e.g., Git)

Job description

Project Role:

Senior Clinical Database Programmer- Python/R

Work Experience:

8+ Years

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
• 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:
  • 21 CFR Part 11
  • IQVIA SOPs and validation standards
• Review and approve programming documentation, specifications, and outputs as required
• Serve as a senior technical interface with:
  • 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
• 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