Senior Principal, Statistical Programming

🔥 2 minutes ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

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Jazz Pharmaceuticals

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2003

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Jazz Pharmaceuticals is a biopharmaceutical company dedicated to developing innovative medicines that address serious unmet medical needs. With a strong commitment to research and development, Jazz focuses on creating life-changing therapies, emphasizing the importance of collaboration, diversity, and employee engagement in its operations. The company prides itself on transforming patients' lives through its meaningful product offerings and a culture that fosters enthusiasm and flexibility.

📋 Description

• Serve as Lead Statistical Programmer across complex Phase I–IV clinical trials or multi-study project areas • Take accountability for programming deliverables from study startup through final CSR and filing • Author, review, and finalize Statistical Analysis Plans, dataset specifications, and TFL mock shells • Direct study-level programming timelines, resource allocations, and risk mitigation strategies • Architect, program, and validate CDISC-compliant SDTM and ADaM datasets • Create, validate, and troubleshoot statistical tables, figures, and listings 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 • Prepare integrated summaries of safety and efficacy (ISS/ISE) for global regulatory filings and rapid-response inquiries • Provide technical oversight and quality assurance for external CRO and FSP programming deliverables • Review CRO specifications, raw data mappings, analysis datasets, and TFLs • Facilitate data transfer and milestone coordination between internal cross-functional teams and external programming teams • Design, validate, and maintain SAS macros, R functions, automation scripts, and standardized TFL templates • Evaluate and pilot new technologies, automated pipelines, and open-source statistical computing tools • Mentor and develop junior and mid-level statistical programmers through code reviews, best-practice guidance, and technical troubleshooting

🎯 Requirements

• Expert-level proficiency in SAS (Base, Stat, Macro, ODS, Graph) and data manipulation techniques • 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 and SDRG/ADRG documentation • 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 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 • 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

🏖️ Benefits

• Medical, dental and vision insurance • Retirement savings plan • Flexible paid vacation

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