Principal Statistical Programmer

Jazz Pharmaceuticals

1d • $138,400 - $207,600 • Remote

About The Position

The Principal Statistical Programmer is a high-level technical expert and study-level programming lead within the Data Intelligence & Programming Science department. The role leads statistical programming activities for multiple complex clinical trials or compound-level programs in the Neuroscience or Oncology portfolios.

This position provides hands-on technical and operational leadership for the creation, quality control, and delivery of CDISC-compliant SDTM and ADaM datasets, statistical tables, figures, and listings (TFLs), integrated summaries (ISS/ISE), and electronic submission deliverables for global health authorities. The Principal Statistical Programmer also mentors programmers, oversees CRO deliverables, and helps modernize programming standards, reusable macros, and automated workflows.

The role leads programming from study startup through final clinical study reports and regulatory filings, partnering with biostatisticians, clinical scientists, and other cross-functional teams. It also supports regulatory submissions and integrated analyses, maintains programming tools and standards, and provides technical oversight of external programming partners.

Requirements

• Expert-level proficiency in SAS, including Base, Stat, Macro, ODS, and Graph, and data manipulation techniques.
• Proven proficiency or working knowledge of R or Python in a validated clinical environment.
• Thorough mastery of CDISC SDTM and ADaM models, Define.xml generation, and Pinnacle 21 validation tools.
• Demonstrated hands-on experience authoring regulatory submission-level deliverables, including ISS/ISE integration and SDRG/ADRG documentation, and direct experience supporting an NDA, BLA, or MAA submission.
• Ability to resolve complex programming logic challenges, design efficient data algorithms, and optimize data workflows.
• Exceptional communication skills and ability to collaborate with Biostatisticians, Data Managers, Medical Monitors, and Regulatory Operations.
• Thorough knowledge of ICH/GCP guidelines, 21 CFR Part 11, computer systems validation (CSV) principles, and standard operating procedures governing clinical reporting.
• Bachelor’s, Master’s, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline.
• At least 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry, or 6 or more years with an advanced degree.
• Proven record serving as primary study or program lead programmer for multiple clinical studies across early- or late-stage development.

Nice To Haves

• Direct experience supporting at least one major regulatory filing (NDA, BLA, MAA) or complex integrated analysis (ISS/ISE) is strongly preferred.

Responsibilities

• Lead statistical programming for complex Phase I–IV clinical trials or multi-study project areas, taking accountability for 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 partnership with Study Biostatisticians and Clinical Scientists.
• Direct study-level programming timelines, resource allocations, and risk mitigation to deliver clean data milestones, interim analyses, and final database locks on time.
• Architect, program, and validate CDISC-compliant SDTM and ADaM datasets in accordance with implementation guides, Define.xml requirements, and therapeutic area user guides.
• Create, validate, and troubleshoot statistical tables, figures, and listings for CSRs, safety monitoring committees, and exploratory queries.
• Lead preparation and packaging of electronic submission datasets and documentation, including Define.xml, SDRG/ADRG, and Pinnacle 21 validation reports, in compliance with FDA, EMA, and PMDA standards.
• Prepare integrated summaries of safety and efficacy (ISS/ISE) for global regulatory filings and rapid-response inquiries.
• Provide technical oversight and quality assurance for programming deliverables produced by external CRO partners and FSPs.
• Review CRO specifications, raw data mappings, analysis datasets, and TFLs for alignment with Jazz standards, specifications, and regulatory guidelines.
• Coordinate data transfers and milestones between internal cross-functional teams and external programming teams.
• Design, validate, and maintain departmental SAS macros, R functions, automation scripts, and standardized TFL templates.
• Participate in evaluating and piloting technologies, automated pipelines, and open-source statistical computing tools in a validated environment.
• Mentor and develop junior and mid-level statistical programmers through code reviews, best-practice guidance, and technical troubleshooting.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement savings plan
• Flexible paid vacation
• May be eligible for a discretionary annual cash bonus or incentive compensation, depending on the role
• May be eligible for discretionary equity grants

What This Job Offers

• Job Type: Full-time
• Career Level: Principal