Project Role: Software Developer Analyst 2 (Python & R Programmer)
Work Experience: 5 to 8 Years
Work location: Any IQVIA Office Location in India
Work Mode: Hybrid
Must Have Skills: Python is mandatory skill along with Clinical Data Management or Clinical Domain
Role Summary
The Software Developer Analyst 2 (Python & R programmer) is a mid‑senior individual contributor responsible for independently delivering clinical data programming, transformation, and review solutions in support of global clinical trials.
This role requires hands‑on expertise in Python and R, strong understanding of clinical data standards, and the ability to work with minimal supervision while collaborating closely with Data Managers, Clinical Programmers, Statisticians, and Medical Reviewers throughout the study lifecycle.
Key Responsibilities
Clinical Data Programming & Delivery
- Independently develop and maintain Python and R programs for:
- Clinical data cleaning
- Data transformation
- Data review and analysis
- Support downstream clinical data programming activities as defined in the Data Management Plan (DMP)
- Create and maintain data review listings, metrics, and utilities to support ongoing study conduct and database lock activities
Data Review & Quality Oversight
- Perform detailed clinical data quality checks, trend analysis, and issue identification
- Support ongoing data review, reconciliation, and query resolution
- Ensure programming outputs meet accuracy, traceability, and audit readiness requirements
- Actively support interim and final database lock deliverables
Standards, Compliance & Best Practices
- Apply and interpret CDISC standards (SDTM) in programming and data review
- Ensure compliance with ICH‑GCP, 21 CFR Part 11, and internal SOPs
- Follow validated programming and documentation practices
- Contribute to inspection‑ready deliverables
Cross‑Functional Collaboration
- Work closely with:
- Data Managers
- Clinical Programmers
- Statisticians
- Medical Reviewers
- Participate in cross‑functional discussions related to data issues, timelines, and deliverables
- Provide technical input during study start‑up, conduct, and close‑out phases
Automation & Continuous Improvement
- Develop reusable Python/R utilities and scripts to improve efficiency
- Contribute to process automation, standardization, and innovation initiatives
- Identify opportunities to reduce manual effort in data review and reporting
Required Skills & Qualifications
Technical Skills (Mandatory)
- Strong hands‑on experience in Python and R
- Proficiency with:
- Python: Pandas, NumPy
- R for statistical analysis and data exploration
- Strong SQL skills
- Proven experience working with clinical trial data
- Solid understanding of CDISC / SDTM standards
- Experience in regulated clinical data environments
Tools & Systems
- Clinical data systems (EDC / CDB / CDMS)
- Data review and reporting tools
- Version control systems (e.g., Git)
- Experience supporting data ingestion and transformation workflows
Education
- Bachelor's or Master's degree in:
- Computer Science
- Statistics
- Data Science
- Life Sciences
- Engineering
