[Hiring] Principal Statistical Programmer @Jazz Pharmaceuticals

Role 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.

Qualifications

• Master’s, Master’s, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline.
• Minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry (or 6+ years with an advanced degree).
• Proven track record of serving as the primary study or program lead programmer for multiple clinical studies across early- or late-stage development.
• Direct experience supporting at least one major regulatory filing (NDA, BLA, MAA) or complex integrated analysis (ISS/ISE) is strongly preferred.

Requirements

• Expert-level proficiency in SAS (Base, Stat, Macro, ODS, Graph) and data manipulation techniques, with proven proficiency or working knowledge of R/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 submission-level deliverables, including ISS/ISE integration, SDRG/ADRG documentation, and direct experience supporting an NDA, BLA, or MAA submission.
• Proven ability to resolve complex programming logic challenges, design efficient data algorithms, and optimize heavy data workflows.
• Exceptional communication skills with the ability to collaborate effectively 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.

Benefits

• Medical, dental and vision insurance.
• 401k retirement savings plan.
• Flexible paid vacation.
• Discretionary annual cash bonus or incentive compensation.
• Discretionary equity grants in accordance with Jazz’s Long Term Equity Incentive Plan.