Principal Statistical Programmer
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Role details
Tech stack
Job description
Program Leadership: Lead statistical programming across multiple trials or programs; guide both internal and external teams.
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Team & Line Management: Mentor junior staff; act as functional manager for associates; represent Statistical Programming at governance meetings.
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Technical Expertise: Strong SAS, R, CDISC SDTM/ADaM/Define.xml, eCTD knowledge; familiarity with eCRF/data structures.
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Deliverable Quality: Ensure QC, validation, audit readiness, and regulatory inspection readiness; deliver datasets and outputs for CSRs, safety reports, publications.
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Cross-functional Collaboration: Partner with clinical, statistical, HEOR, and IT teams; coordinate with external vendors.
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Innovation & Process Improvement: Lead process improvements, apply new analytics capabilities, HTA/HEOR solutions, advanced tools (R/Shiny, automation).
Requirements
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Education: Advanced degree in Statistics, Computer Science, Biostatistics, Life Sciences, or related field.
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Experience: 10+ years in statistical programming within pharma/biotech; expertise across clinical trial Phases I-IV, regulatory submissions, CDISC, RWE, HEOR, HTA.
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Technical Skills: Proficient in SAS & R; Python, Shiny preferred; solid understanding of clinical data standards.
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Soft Skills: Strong leadership, mentorship, presentation, and negotiation skills; problem-solving ability and judgment in regulatory/technical contexts.
About the company
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at [click to reveal website link]https://jobs.iqvia.com
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