Position: Senior Statistical Programmer I
Location: India
Job Code: 2025-118262
Department: Programming – ICON Strategic Solutions
Manager: Himangshu Skekhar Das
About the Role:
As a Senior Statistical Programmer I at ICON, you will contribute to high-quality clinical research by creating regulatory-compliant statistical deliverables, leveraging your expertise in SAS/R programming and regulatory submissions (e.g., FDA, EMEA).
Key Responsibilities:
Create ADaM datasets following current ADaM standards.
Develop Tables, Listings, Figures (TLFs) based on specifications.
Generate Subject Narratives as per templates.
Handle clinical registry reporting files (e.g., ClinTrials.gov, EudraCT).
Perform Quality Control (QC) on all outputs.
Maintain detailed specification documentation.
Develop and validate electronic submission packages for FDA, EMEA, etc.
Support both standalone studies and integrated study data.
Must-Have Requirements:
Minimum 8+ years of relevant experience in statistical programming.
2+ years of experience as trial lead or in SAS/R development for broad clinical applications.
Strong leadership and organizational skills for managing multiple priorities.
In-depth understanding of clinical trial data, including safety, efficacy, and PK/PD.
Experience with Base SAS and Macro programming.
Proven ability to review/write specifications and collaborate with cross-functional teams.
Expertise in submission standards and requirements across major regulatory bodies.
What ICON Offers:
Competitive salary and performance-based rewards.
Country-specific annual leave entitlements.
Health insurance for you and your family.
Attractive retirement planning options.
Access to the TELUS Health Global Employee Assistance Programme (24/7).
Additional benefits such as:
Childcare vouchers
Discounted gym memberships
Subsidized travel passes
Health assessments
Bike purchase schemes
Equal Opportunity Employer Statement:
ICON is committed to building an inclusive work environment. We welcome applicants from all backgrounds and ensure fair treatment regardless of race, gender, religion, disability, or veteran status. Reasonable accommodations are available for candidates with medical conditions or disabilities.
To Apply:
Visit the job slug: senior-statistical-programmer-i-india-2025-11826
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