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Assoc. Principal Stat Programmer

10+ years
Not Disclosed
10 Sept. 23, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Associate Principal Statistical Programmer

Location: Thāne, India
Job ID: R1480445
Job Type: Full-time
Work Mode: Home-based
Additional Locations: Available


Company Overview

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. The company leverages science, data, and technology to accelerate the development and commercialization of innovative medical treatments, improving patient outcomes and population health worldwide.

Learn more about IQVIA Careers


Job Overview

We are seeking an experienced Statistical Programmer with expertise in ADaM and TFL programming, primarily for Oncology and Immunology clinical studies. The role involves developing efficacy ADaMs and TFLs, including complex plots and analyses for Phase 2 and 3 clinical trials.


Key Responsibilities

  • Develop and validate ADaM datasets and Tables, Figures, and Listings (TFLs) for efficacy analyses.

  • Work on oncology/immunology studies, including endpoints such as:

    • ADTTE – PFS (Progression-Free Survival)

    • OS (Overall Survival)

    • DOR (Duration of Response)

    • BOR (Best Overall Response)

    • ORR (Objective Response Rate)

  • Create and interpret KM plots (Kaplan-Meier), waterfall plots, and forest plots for clinical trial data.

  • Ensure compliance with regulatory standards and statistical programming guidelines for Phase 2 and Phase 3 studies.

  • Collaborate with biostatisticians, data managers, and clinical teams to ensure accurate and timely deliverables.


Qualifications

  • Experience: Minimum 10+ years in statistical programming.

  • Technical Skills:

    • Expertise in ADaM datasets and TFL programming.

    • Strong knowledge of oncology/immunology efficacy endpoints.

    • Experience in creating KM, waterfall, and forest plots.

  • Preferred: Experience in Phase 2 and Phase 3 clinical trials.


Application

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