Statistical Programmer II – SDTM | ICON, India
Job Summary
ICON plc is hiring a Statistical Programmer II with expertise in SDTM and clinical data standards to support global clinical research projects. Based in Chennai, Bangalore, or Trivandrum, this role offers a dynamic opportunity to contribute to regulatory submissions, safety data review, and electronic submission package development. If you have 4+ years of experience in SAS, SDTM, and related tools, this is a prime opportunity to join one of the world's leading healthcare intelligence organizations.
Key Responsibilities
Review and contribute to trial setup documentation
Create and maintain SDTM datasets per current CDISC standards
Develop data review models and backend edit checks for data quality
Conduct QC of all programming deliverables
Support unblinding and data cut activities for reporting milestones
Develop electronic submission packages for regulatory agencies
Use tools like Spotfire, Tableau, or Oracle BI for analytics and visualizations
Support standards development and drive their implementation across teams
Required Skills & Qualifications
Minimum 4 years of statistical programming experience in clinical research
Proficiency in SAS, SQL, Python, or R for data manipulation and reporting
Strong expertise in SDTM, Define.xml, CDASH, metadata transformation
Experience with data types such as biomarkers, ECG, and imaging data
Familiarity with visualization tools: Tableau, Qlik, Spotfire, JReview, etc.
Knowledge of AdaM standards is a plus
Attention to detail, strong analytical and documentation skills
Perks & Benefits
Competitive salary package (not disclosed in JD)
Annual leave entitlements
Comprehensive health insurance for employee and dependents
Retirement planning options
Life assurance and global Employee Assistance Programme (TELUS Health)
Optional benefits: gym discounts, childcare vouchers, travel subsidies, and more
Company Description
ICON plc is a global leader in clinical research and healthcare intelligence. With operations in over 40 countries, ICON delivers trusted data and biometrics solutions to support life sciences, pharmaceuticals, and biotechnology organizations in improving patient outcomes.
Work Mode: On-site or Hybrid (Chennai, Bangalore, Trivandrum)
Call-to-Action
Ready to make an impact in the world of clinical research programming? Apply now to join ICON and advance your career in biometrics with global exposure and innovation at the core.
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