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Statistical Programmer Ii

4+ years
Not Disclosed
10 June 5, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Meta Title:

Statistical Programmer II Job – ICON India | Apply Now

Meta Description:

Apply for Statistical Programmer II role at ICON in India. SAS programming, ADaM, CDISC, and FDA submission skills required. Competitive salary & benefits.

Meta Keywords:

Statistical Programmer Jobs India, Clinical SAS Jobs, ICON Careers India, CDISC ADaM Programmer, SAS Pharma Jobs, Biostatistics Jobs Chennai, Bangalore, Trivandrum, Remote Clinical Research Jobs India

Job Summary

ICON plc, a global leader in healthcare intelligence and clinical research, is hiring a Statistical Programmer II to join its expanding Biometrics team in India. This is a pivotal role supporting programming activities aligned with regulatory submissions, ADaM datasets, and clinical trial data outputs. If you're experienced in SAS, CDISC, and clinical data standards, this opportunity offers immense growth in a highly specialized pharmaceutical data domain.


 Key Responsibilities

  • Develop ADaM datasets in compliance with CDISC and sponsor-specific standards.

  • Program Tables, Listings, and Figures (TLFs) to support clinical trial submissions.

  • Generate and QC Subject Narratives using standard templates.

  • Contribute to clinical registry reporting (e.g., ClinicalTrials.gov, EudraCT).

  • Support regulatory deliverables including FDA and EMA submissions.

  • Maintain detailed documentation including specifications and validation reports.

  • Ensure all programming adheres to Johnson & Johnson SOPs, ICH-GCP, and local regulatory requirements.


 Required Skills & Qualifications

  • Bachelor's or Master’s in Computer Science, Mathematics, Life Sciences, or related field.

  • Minimum 4+ years of experience in statistical programming within clinical trials.

  • Expertise in SAS (Base and Macro) programming.

  • Familiarity with clinical trial data across safety, efficacy, and PK/PD domains.

  • Strong grasp of regulatory submission requirements (FDA, EMA).

  • Demonstrated experience with CDISC standards, particularly ADaM.

  • Excellent communication and documentation skills.


 Perks & Benefits

  • Competitive industry salary (Exact range not listed; varies by location and experience).

  • Comprehensive health insurance packages for employees and families.

  • Generous annual leave policies.

  • Retirement planning options tailored to local standards.

  • Access to TELUS Health (global employee assistance program).

  • Life assurance and income protection schemes.

  • Optional benefits: gym membership discounts, childcare vouchers, commute subsidies, and more.


 About ICON plc

ICON plc is a world-leading CRO providing outsourced development services to pharmaceutical, biotech, and medical device organizations. We specialize in biometrics, regulatory affairs, pharmacovigilance, and clinical operations, accelerating drug development with data-driven precision.


 Work Mode

Hybrid – Office-based in Chennai, Bangalore, or Trivandrum, with flexibility available based on project needs.


 Call to Action

Ready to take the next step in your pharmaceutical data programming career?
Click below to apply now and join a global organization transforming clinical development.

Apply Now at ICON Careers