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Principal Statistical Programer

10+ years
Not Disclosed
10 April 29, 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

Principal Statistical Programmer
Location: Hyderabad, India
Job Type: Full Time
Job ID: R1461117

Job Description

IQVIA is seeking an experienced Principal Statistical Programmer with a minimum of 10 years of experience in ADaM and TFL programming, specifically in Oncology/Immunology studies. The ideal candidate will have expertise in efficacy ADaMs and TFLs, including ADTTE (Progression-Free Survival, Overall Survival, Duration of Response, Best Overall Response, and Objective Response Rate). Experience with KM plots, waterfall plots, and forest plots is essential, along with Phase 2/3 study experience.

Key Responsibilities

  • Statistical Programming: Lead programming activities related to ADaM and TFLs, ensuring quality and compliance with industry standards.

  • Oncology/Immunology Studies: Focus on efficacy ADaMs and TFLs related to key oncology/immunology metrics such as PFS, OS, DOR, BOR, and ORR.

  • Plot Creation: Develop and interpret KM plots, waterfall plots, and forest plots for study data.

  • Study Management: Provide guidance on statistical programming tasks, including handling complex datasets and ensuring the integrity of statistical analyses.

  • Collaboration: Work closely with cross-functional teams, including biostatisticians and clinical data management teams, to support project goals.

  • Data Quality: Review and validate statistical programming outputs to ensure data quality and accuracy.

Required Qualifications & Skills

  • Education: Bachelor’s or Master’s degree in a relevant field (e.g., Statistics, Mathematics, Computer Science).

  • Experience: 10+ years of experience in statistical programming, with expertise in ADaM and TFL programming.

  • Specialized Knowledge:

    • Strong experience in oncology/immunology studies, including ADTTE, PFS, OS, DOR, BOR, and ORR.

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

    • Experience in Phase 2 and 3 clinical trials is preferred.

  • Technical Skills:

    • Strong programming skills in SAS and other relevant software.

    • In-depth knowledge of clinical trial data, regulatory requirements, and industry best practices.

    • Ability to lead and mentor junior programmers and collaborate with other stakeholders.

About IQVIA

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We connect data, technology, and expertise to accelerate the development and commercialization of innovative medical treatments.


Location: Hyderabad, India
Worker Type: Full Time

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IQVIA is an equal opportunity employer, committed to diversity and inclusion.