Principal Statistical Programmer

Jazz Pharmaceuticals•Philadelphia, PA

20h•Remote

About The Position

The Principal Statistical Programmer is a high-level technical expert and study-level programming lead in the Data Intelligence & Programming Science department. The role leads statistical programming across multiple complex clinical trials or compound-level programs in the Neuroscience or Oncology portfolios, with accountability for programming deliverables from study startup through final clinical study report and regulatory filing. The position provides hands-on technical and operational leadership for CDISC-compliant SDTM and ADaM datasets, statistical tables, figures, and listings (TFLs), integrated safety and efficacy summaries (ISS/ISE), and electronic submission deliverables. It also oversees CRO deliverables, mentors programmers, and contributes to departmental programming standards, reusable code, and automated workflows. The role collaborates with biostatistics, clinical, data management, medical monitoring, regulatory operations, and external programming teams. For U.S.-based candidates, the stated base pay range is $138,400 to $207,600. The successful candidate may also be eligible for discretionary annual cash bonus or incentive compensation and equity grants, and may participate in medical, dental, vision, 401(k), and flexible paid vacation benefits.

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.
Hands-on experience authoring submission-level deliverables, including ISS/ISE integration and SDRG/ADRG documentation, and 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 and collaboration skills with biostatisticians, data managers, medical monitors, and regulatory operations.
Thorough knowledge of ICH/GCP guidelines, 21 CFR Part 11, computer systems validation principles, and clinical reporting SOPs.
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.
A track record of 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, or MAA) or complex integrated analysis (ISS/ISE) is strongly preferred.

Responsibilities

Lead statistical programming for complex Phase I–IV trials or multi-study project areas, managing deliverables from study startup through final CSR and filing.
Author, review, and finalize Statistical Analysis Plans, dataset specifications, and TFL mock shells in partnership with study biostatisticians and clinical scientists.
Direct programming timelines, resource allocation, and risk mitigation for data milestones, interim analyses, and final database locks.
Architect, program, and validate CDISC-compliant SDTM and ADaM datasets, including compliance 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 using SAS, R, and modern programming packages.
Lead preparation and packaging of electronic submission datasets and documentation, including Define.xml, SDRG/ADRG, and Pinnacle 21 validation reports, to meet 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 CRO partners and functional service providers.
Review CRO specifications, raw data mappings, analysis datasets, and TFLs for alignment with company 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.
Evaluate and pilot new technologies, automated pipelines, and open-source statistical computing tools within a validated environment.
Mentor junior and mid-level statistical programmers through code reviews, best-practice guidance, and technical troubleshooting.