Job Title: Statistical Programmer II
Company: ICON plc – Strategic Solutions
Location: India
Job ID: 2025-118458
About the Role:
Join ICON plc, the world’s largest and most comprehensive clinical research organization, as a Statistical Programmer II. In this role, you will contribute to the Submissions Center of Excellence, supporting regulatory submission activities and ensuring clinical data packages are compliant and submission-ready.
Key Responsibilities:
Contribute to the Submissions Center of Excellence, staying updated with the latest global regulatory submission standards.
Support post-database lock activities, ensuring SDTM and ADaM datasets meet regulatory requirements.
Prepare Define.pdf documents, execute final P21E checks, and validate submission metadata.
Resize datasets, remove empty variables, and perform final formatting for submission readiness.
Verify the accuracy of cSDRG/ADRG explanations, ensure proper bookmarking and document properties in submission PDFs.
Although dataset and TFL programming remains with trial clinical/statistical programmers, you will play a vital role in final regulatory data preparation.
Qualifications & Experience:
Experience with regulatory submissions is preferred.
Knowledge of SDTM and ADaM dataset structures and familiarity with submission standards and tools.
Detail-oriented with an understanding of clinical trial data programming.
Capable of interpreting and implementing regulatory guidelines and best practices.
What ICON Offers You:
ICON fosters a high-performance culture and a supportive work environment, with benefits designed to ensure your personal and professional well-being:
Generous annual leave entitlements.
Flexible health insurance packages for individuals and families.
Competitive retirement plans for future security.
Global Employee Assistance Programme (TELUS Health): 24/7 access to expert support for you and your family.
Life assurance coverage.
Optional benefits by location, including childcare vouchers, bike-to-work schemes, discounted gym memberships, subsidised travel, and health assessments.
Learn more at ICON Careers – Benefits
Diversity & Inclusion:
ICON is committed to equality, inclusion, and accessibility. All applicants are considered without bias regarding race, gender, orientation, or background. Reasonable accommodations are available throughout the recruitment process. Learn more: Reasonable Accommodations
Note:
Even if you don’t meet all the qualifications, ICON encourages you to apply — you might be exactly what the team needs for this or future opportunities.
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