Principal Statistical Programmer
Role details
Job location
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.