Senior Principal, Statistical Programming

If you are a current Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.

Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit  for more information.

Job Description Brief

Description:

The Principal Statistical Programmer is a high-level technical expert and study-level programming lead within the Data Intelligence & Programming Science department. This individual is responsible for leading statistical programming activities for multiple complex clinical trials or entire compound-level programs across our Neuroscience or Oncology portfolios.

The Principal Statistical Programmer provides hands-on technical and operational leadership, overseeing the creation, quality control, and delivery of CDISC-compliant datasets (SDTM and ADaM), statistical tables, figures, and listings (TFLs), integrated summaries (ISS/ISE), and electronic submission deliverables for global health authorities. Additionally, this role mentors junior and senior programmers, oversees contract research organization (CRO) deliverables, and contributes to the modernization of departmental programming standards, reusable macros, and automated workflows.

Essential Functions/Responsibilities Study & Program-Level Technical Leadership
• Serve as the Lead Statistical Programmer across complex Phase I–IV clinical trials or multi-study project areas, taking accountability for all programming deliverables from study startup through final CSR and filing.
• Author, review, and finalize Statistical Analysis Plans (SAPs), dataset specifications, and TFL mock shells in close partnership with Study Biostatisticians and Clinical Scientists.
• Direct study-level programming timelines, resource allocations, and risk mitigation strategies to ensure timely delivery of clean data milestones, interim analyses, and final database locks.

CDISC Implementation & Regulatory Submissions
• Architect, program, and validate CDISC-compliant SDTM and ADaM datasets, ensuring strict conformance with standard implementation guides, define.xml requirements, and therapeutic area user guides (TAUGs).
• Create, validate, and troubleshoot complex statistical tables, figures, and listings for Clinical Study Reports (CSRs), Safety Monitoring Committees (IDMC/DSMB), and exploratory queries using SAS, R, and modern programming packages.
• Lead the preparation and packaging of electronic submission datasets and documentation (Define.xml, Reviewer’s Guides [SDRG/ADRG], Pinnaccle 21 validation reports) in compliance with FDA, EMA, and PMDA standards.
• Prepare integrated summaries of safety and efficacy (ISS/ISE) to support global regulatory filings (NDA/BLA/MAA) and rapid-response inquiries.

Vendor Oversight & Technical Review
• Provide direct technical oversight and quality assurance for programming deliverables executed by external CRO partners and functional service providers (FSPs).
• Review CRO-generated specifications, raw data mappings, analysis datasets, and TFLs to ensure strict alignment with Jazz standards,…