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Senior Statistical Programmer I

Icon Plc
ICON PLC
6+ years
Not Disclosed
10 Dec. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc. 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

 

The Senior Statistical Programmer I role focuses on programming and quality assurance of SDTM (Study Data Tabulation Model) datasets for clinical trials. Key responsibilities include:

  1. Data Review & Processing:

    • Interact with vendors to receive and review CRF (Case Report Forms) and external data (e.g., LAB, ECG, PK).
    • Ensure data complies with standards for easy integration into the system.
    • Use SAS programming to compare CRF and external data, and issue queries based on discrepancies.
  2. SDTM Dataset Creation:

    • Build SDTM datasets using a GUI interface (DSP), which generates SAS code.
    • Create trial design domains based on protocol/CRF and validate SDTM datasets using tools like Pinnacle 21.
  3. Documentation & Quality Control:

    • QC SDTM datasets, specifications, documentation, and annotations.
    • Troubleshoot programming issues and create SAS tools to improve team processes (e.g., data conversion programs).
  4. Team Collaboration:

    • Work with data managers, clinical programmers, statisticians, medical coders, and external vendors.

Qualifications:

  • 6+ years of SDTM experience.
  • At least 2 years of trial lead experience or developing SAS/R solutions.
  • Expertise in SAS Base and Macro, and industry standards for clinical data submissions.

What ICON Offers:

  • Competitive salary and benefits, including health insurance, retirement planning, life assurance, and wellness programs.
  • Focus on diversity, inclusion, and employee well-being.

If you're interested but unsure about meeting all the requirements, ICON encourages you to apply, as there may be other suitable opportunities.