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Principal Stat Programmer

10+ years
Not Disclosed
10 Dec. 27, 2024
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

Job Title: Senior Programmer – ADaM and TFL Programming (Oncology/Immunology)

Location: Various Locations, based on project needs
Company: IQVIA


Company Overview:

IQVIA is a global leader in providing clinical research services, healthcare intelligence, and commercial insights to the life sciences and healthcare industries. We accelerate the development and commercialization of innovative medical treatments, helping improve patient outcomes and health worldwide.


Role Overview:

We are seeking Senior Programmers with 10+ years of experience in ADaM and TFL programming for clinical trials, specifically in Oncology/Immunology studies. You will play a key role in the preparation and analysis of clinical data, working on efficacy ADaMs and TFLs, including ADTTE, PFS, OS, DOR, BOR, ORR data. Proficiency in KM plots, waterfall plots, and forest plots is essential, with experience in Phase 2 and 3 clinical trials preferred.


Key Responsibilities:

  • ADaM and TFL Programming: Develop and maintain ADaM datasets and TFLs, ensuring they meet study requirements and regulatory standards.
  • Oncology/Immunology Focus: Work specifically on efficacy endpoints such as PFS (Progression-Free Survival), OS (Overall Survival), DOR (Duration of Response), BOR (Best Overall Response), and ORR (Objective Response Rate) in Oncology and Immunology studies.
  • Visualization: Create and validate KM plots, waterfall plots, and forest plots for clinical trial reporting.
  • Clinical Trial Phases: Focus primarily on Phase 2 and Phase 3 clinical trials, contributing to statistical analysis and interpretation.
  • Collaboration: Work closely with clinical data teams, statisticians, and other stakeholders to ensure timely and accurate data delivery.
  • Regulatory Compliance: Ensure that programming deliverables are compliant with regulatory standards and company SOPs.

Qualifications:

  • Experience:
    • 10+ years of experience in ADaM and TFL programming.
    • Proven experience working with Oncology/Immunology studies and familiarity with efficacy-related ADaMs and TFLs (e.g., ADTTE, PFS, OS, DOR, BOR, ORR).
    • Expertise in creating and interpreting KM plots, waterfall plots, and forest plots.
    • Experience in Phase 2 and Phase 3 clinical trials is preferred.
  • Technical Skills:
    • Proficiency in SAS programming and statistical software.
    • Solid understanding of clinical trial processes, data standards, and reporting requirements.
    • Knowledge of CDISC standards, particularly ADaM and SDTM.
  • Additional Skills:
    • Strong communication and collaboration skills.
    • Ability to work independently and manage multiple priorities.

What IQVIA Offers:

  • Competitive Compensation: Based on experience and qualifications.
  • Career Growth: Opportunities for career advancement in a globally recognized company.
  • Comprehensive Benefits: Health coverage, retirement savings, wellness programs, and more.

How to Apply:

To explore this opportunity and apply, please visit the IQVIA Careers Page.


EEO & COVID-19 Requirements:

IQVIA is an equal opportunity employer and complies with all employment laws and regulations. IQVIA may have specific COVID-19 vaccination requirements depending on the role and location. Learn more at COVID-19 Vaccine Status.


Compensation & Benefits:

  • Competitive salary based on experience.
  • Comprehensive benefits package including health, dental, and vision insurance, retirement plans, and more.