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About the Role
The Principal Statistical Programmer is a high-level technical expert and study-level programming lead responsible for leading statistical programming activities for multiple complex clinical trials or entire compound-level programs. This role provides hands-on technical and operational leadership, overseeing the creation, quality control, and delivery of CDISC-compliant datasets, statistical tables, figures, and listings, integrated summaries, and electronic submission deliverables. 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.
Responsibilities
- 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.
- 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.
- 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, specifications, and regulatory guidelines.
- Facilitate smooth data transfer and milestone coordination between internal cross-functional teams and external programming teams.
- Design, validate, and maintain global departmental SAS macros, R functions, automation scripts, and standardized TFL templates to enhance productivity and code reproducibility.
- Participate in the evaluation and piloting of new technologies, automated pipelines, or open-source statistical computing tools within a validated environment.
- Actively mentor and develop junior and mid-level statistical programmers, providing code reviews, best practices guidance, and technical troubleshooting support.
Requirements
- Mastery of Statistical Programming: 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.
- CDISC & Regulatory Standards: Thorough mastery of CDISC SDTM and ADaM models, Define.xml generation, and Pinnacle 21 validation tools.
- Regulatory Filing Experience: 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.
- Analytical & Problem-Solving Capabilities: Proven ability to resolve complex programming logic challenges, design efficient data algorithms, and optimize heavy data workflows.
- Cross-Functional Collaboration: Exceptional communication skills with the ability to collaborate effectively with Biostatisticians, Data Managers, Medical Monitors, and Regulatory Operations.
- Quality & GxP Compliance: Thorough knowledge of ICH/GCP guidelines, 21 CFR Part 11, computer systems validation (CSV) principles, and standard operating procedures governing clinical reporting.
Skills
- SAS (Base, Stat, Macro, ODS, Graph)
- R
- Python
- CDISC SDTM
- CDISC ADaM
- Define.xml
- Pinnacle 21
- ICH/GCP guidelines
- 21 CFR Part 11
- Computer systems validation (CSV)
Location
- Remote
Work Type
- Remote
- Full-time
Experience Level
- 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.
Education Level
- Bachelor’s, Master’s, or Ph.D. degree in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline.
Salary/Compensations
- $138,400.00 - $207,600.00
Benefits
- Discretionary annual cash bonus or incentive compensation
- Discretionary equity grants
- Medical insurance
- Dental insurance
- Vision insurance
- 401k retirement savings plan
- Flexible paid vacation
About the Company
- Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families.
- Dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options.
- Has a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments.
- Patient-focused and science-driven approach powers pioneering research and development advancements across its robust pipeline of innovative therapeutics in oncology and neuroscience.
- Headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.
- Visit www.jazzpharmaceuticals.com for more information.
Equal Opportunity
- Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.