Statistical Programmer II – Clinical Research | ICON, India
Job Summary:
ICON Strategic Solutions is hiring a Statistical Programmer II to support regulatory submissions and post-database lock deliverables for global clinical trials. This India-based role offers the opportunity to work with one of the world's leading CROs, leveraging advanced statistical programming skills to ensure compliance with regulatory standards such as CDISC, ADaM, and SDTM.
This role is ideal for candidates with a strong background in define.xml, P21, SDRG/ADRG, and hands-on experience preparing data packages for submission to regulatory agencies.
Key Responsibilities:
Contribute to the Submissions Center of Excellence by preparing datasets and documentation for regulatory submission
Stay updated on the latest regulatory requirements impacting clinical data submissions
Execute final programming tasks including resizing datasets and removing empty variables
Generate high-quality define.pdf files, perform P21E validation runs
Ensure all data annotations and explanations in cSDRG/ADRG are correct and compliant
Format and bookmark PDF documents according to submission guidelines
Required Skills & Qualifications:
Proficient in define.xml, P21, SDRG, ADRG
Hands-on experience with SDTM and ADaM datasets
Strong understanding of CDISC standards and regulatory submission processes
Experience with post-database lock activities in clinical trials
Previous experience submitting data to regulatory authorities preferred
Excellent attention to detail and documentation standards
Perks & Benefits:
Competitive salary (not disclosed in JD)
Generous annual leave entitlements
Comprehensive health insurance options for you and your family
Retirement planning and savings benefits
Life assurance coverage
Flexible benefits such as childcare vouchers, discounted gym memberships, and more
24/7 Global Employee Assistance Program (TELUS Health)
A culture committed to inclusion, accessibility, and professional growth
Company Description:
ICON plc is a global leader in healthcare intelligence and clinical research. With operations in over 40 countries, ICON delivers strategic solutions to support the development of life-changing therapies. ICON's culture of inclusion, innovation, and excellence makes it a top destination for clinical research professionals worldwide.
Work Mode: Remote or Hybrid (based in India)
Salary Range: Not specified (competitive compensation offered)
Call to Action:
If you’re a clinical data expert ready to take your statistical programming career to the next level, apply now and be part of a mission-driven team that advances healthcare innovation globally.
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