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Statistical Programmer Ii

4+ years
Not Disclosed
10 July 18, 2025
Job Description
Job Type: Remote 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

 

Job Title: Statistical Programmer II

Location: Remote (India)
Company: ICON Strategic Solutions


Job Summary:

ICON is hiring a Statistical Programmer II to join its global clinical research team. This remote opportunity is ideal for professionals with 4+ years of experience in statistical programming using SAS in the context of clinical trials. The role involves creation and QC of ADaM datasets, TLFs, and regulatory submission support using CDISC standards. Be part of an organization that leverages healthcare intelligence to drive meaningful impact in drug development.


Key Responsibilities:

  • Develop ADaM datasets following current CDISC ADaM standards

  • Generate Tables, Listings, and Figures per sponsor specifications

  • Support development of subject narratives using pre-defined templates

  • Program ancillary data streams (e.g., ClinTrials.gov, EudraCT, BIMO reports)

  • Perform QC of all programmed outputs

  • Document and maintain detailed specifications

  • Create and validate electronic submission packages (FDA, EMEA)

  • Support data integration across standalone and multi-study submissions


Required Skills & Qualifications:

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

  • Proficiency in SAS Base and Macro programming

  • Strong understanding of clinical data including safety, efficacy, PK/PD

  • Familiarity with CDISC ADaM, SDTM, Controlled Terminologies

  • Experience with ADaM metadata, SAS code, and TAUG is a plus

  • Working knowledge of regulatory submission requirements


Perks & Benefits:

  • Competitive salary package

  • Multiple annual leave entitlements

  • Health insurance plans for you and your family

  • Retirement planning benefits

  • Life assurance coverage

  • Global Employee Assistance Programme

  • Country-specific perks (e.g., gym discounts, health assessments, travel passes)


Company Description:

ICON plc is a global leader in clinical research and healthcare intelligence. With a commitment to quality, diversity, and innovation, ICON supports sponsors in delivering impactful therapies. The company fosters an inclusive culture, where talent and performance are nurtured across all roles in the life sciences domain.


Work Mode:

Remote – Work from anywhere in India


Call to Action:

Ready to contribute to high-impact clinical research and grow your programming career? Apply now to become a part of ICON's award-winning global team.