Brief 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.

Essential Functions/Responsibilities

Study & Program-Level Technical Leadership

•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.

CDISC Implementation & Regulatory Submissions

•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.

Vendor Oversight & Technical Review

•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.

Innovation, Standards & Departmental Development

•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.

Required Knowledge, Skills, and Abilities

•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.

Required/Preferred Education and Licenses

•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.

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