Senior SDTM Programmer – Remote | ICON India
Job Summary:
ICON plc, a global leader in healthcare intelligence and clinical research, is hiring a Senior Statistical Programmer specializing in SDTM. This remote role offers you the opportunity to lead programming efforts for clinical trials, develop regulatory submission packages, and drive standards implementation across therapeutic areas. If you bring 6+ years of programming experience, expertise in SAS, SDTM, and regulatory compliance, this is your chance to make a global impact in the pharma and life sciences industry.
Key Responsibilities:
Review and contribute to trial setup documents including aCRFs and data transfer agreements.
Develop and maintain SDTM datasets and Data Review Models (DRM) per sponsor and regulatory standards.
Create backend edit checks, visualizations, and listings to support risk-based monitoring.
Conduct unblinding and data cut activities for reporting milestones and database locks.
Develop and validate e-submission packages for FDA, EMEA, and other regulatory bodies.
Drive the implementation of programming standards across clinical programs or therapeutic areas.
Required Skills & Qualifications:
Minimum 6+ years of experience in statistical programming, with increasing responsibilities.
At least 2 years of experience as a trial lead or programming lead.
Strong hands-on experience with SAS, SDTM, Python, R, SQL, and visualization tools like Spotfire.
Advanced understanding of clinical data structures including biomarkers, ECG, and imaging data.
Familiarity with CDISC standards, ICH-GCP guidelines, and regulatory submission processes.
Excellent communication, leadership, and problem-solving skills.
Perks & Benefits:
Competitive salary and performance-based rewards.
Country-specific leave policies and retirement planning options.
Health insurance plans tailored to individual and family needs.
Global Employee Assistance Program (TELUS Health) for mental and emotional wellbeing.
Life assurance and optional benefits like subsidized travel, gym memberships, and more.
Supportive and inclusive culture focused on performance and work-life balance.
Company Description:
ICON plc is a world-renowned provider of clinical research and healthcare intelligence services, working with leading pharmaceutical, biotech, and medical device companies. With a commitment to innovation, diversity, and quality, ICON accelerates the development of drugs and devices that improve patient lives globally.
Work Mode:
Remote – India
Call-to-Action:
If you're passionate about data, compliance, and making a global difference in clinical research, apply now to join ICON as a Senior SDTM Programmer and elevate your programming career in the pharma industry.
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