Associate Principal Statistical Programmer
Location: Thane, India
Job Type: Full-Time | Home-Based
Job ID: R1480445
Job Overview
IQVIA is seeking an experienced Associate Principal Statistical Programmer to lead advanced statistical programming activities across global clinical studies. This role requires deep expertise in ADaM and TFL programming, particularly within Oncology and Immunology trials. The ideal candidate will bring strong analytical capability, hands-on technical proficiency, and experience supporting late-phase clinical development.
Key Responsibilities
• Lead complex statistical programming tasks for ADaM datasets and TFL outputs.
• Drive development of efficacy ADaMs including ADTTE datasets for PFS, OS, DOR, BOR, and ORR.
• Produce and validate high-quality statistical outputs such as KM plots, waterfall plots, and forest plots.
• Support statistical programming deliverables across Phase II and Phase III clinical trials.
• Ensure all programming activities align with regulatory requirements, project timelines, and quality standards.
• Collaborate with biostatisticians, data managers, and global cross-functional teams to ensure accurate and timely deliverables.
• Provide technical oversight, problem-solving support, and guidance to programming teams.
• Contribute to process optimization, standard development, and continuous improvement initiatives.
Required Skills & Expertise
• Strong proficiency in ADaM and TFL programming within clinical research.
• Hands-on experience with efficacy endpoints including PFS, OS, DOR, BOR, and ORR.
• Ability to independently create KM plots, forest plots, and waterfall plots.
• Experience across global Oncology and Immunology studies.
• Deep understanding of CDISC standards, regulatory expectations, and clinical trial methodologies.
• Strong communication, analytical, and documentation skills.
Experience Required
• Minimum 10 years of professional experience in statistical programming within clinical trials.
• Extensive experience in Oncology/Immunology studies, specifically with efficacy ADaMs and TFLs.
• Prior involvement in Phase II and Phase III clinical studies is preferred.
About IQVIA
IQVIA is a global leader in advanced analytics, clinical research, and technology-enabled healthcare solutions. The organization supports the development and delivery of innovative medical treatments to improve patient outcomes worldwide.
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