Principal Statistical Programmer
23 hours ago
Cambridge
If you are a current Jazz employee, please apply via the Internal Career site. \n Welcome to Jazz Pharmaceuticals, a global biopharma company on a mission to innovate and transform the lives of patients and their families. We are dedicated to developing life-changing medicines for individuals facing serious diseases, often with limited or no therapeutic options. Our diverse portfolio includes leading therapies for sleep disorders, epilepsy, and a growing range of cancer treatments. With a patient-focused and science-driven approach, we are pioneering advancements in oncology and neuroscience. Headquartered in Dublin, Ireland, we have research and development laboratories, manufacturing facilities, and dedicated employees across multiple countries, all committed to serving patients worldwide. Join Us as a Principal Statistical Programmer!\n As a Principal Statistical Programmer, you will be a high-level technical expert and study-level programming lead within our Data Intelligence & Programming Science department. This is your opportunity to lead statistical programming activities for multiple complex clinical trials or entire compound-level programs across our Neuroscience or Oncology portfolios. \n In this role, you will provide 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. You will also mentor junior and senior programmers, oversee contract research organization (CRO) deliverables, and contribute to the modernization of departmental programming standards, reusable macros, and automated workflows. Key Responsibilities\n\n • Study & Program-Level Technical Leadership:\n \n, • Lead statistical programming across complex Phase I–IV clinical trials, ensuring accountability for all programming deliverables from study startup through final CSR and filing.\n, • Collaborate closely with Study Biostatisticians and Clinical Scientists to author, review, and finalize Statistical Analysis Plans (SAPs), dataset specifications, and TFL mock shells.\n, • Direct study-level programming timelines, resource allocations, and risk mitigation strategies to ensure timely delivery of clean data milestones.\n \n, • CDISC Implementation & Regulatory Submissions:\n \n, • Architect, program, and validate CDISC-compliant SDTM and ADaM datasets, ensuring strict adherence to standard implementation guides.\n, • Create and troubleshoot complex statistical tables, figures, and listings for Clinical Study Reports (CSRs) using SAS, R, and modern programming packages.\n, • Lead the preparation and packaging of electronic submission datasets and documentation in compliance with FDA, EMA, and PMDA standards.\n \n, • Vendor Oversight & Technical Review:\n \n, • Provide direct technical oversight and quality assurance for programming deliverables executed by external CRO partners.\n, • Review CRO-generated specifications and analysis datasets to ensure alignment with Jazz standards and regulatory guidelines.\n \n, • Innovation, Standards & Departmental Development:\n \n, • Design and maintain global departmental SAS macros, R functions, and standardized TFL templates to enhance productivity.\n, • Participate in evaluating new technologies and automated pipelines within a validated environment.\n, • Mentor junior and mid-level statistical programmers, providing guidance and technical support.\n \nWhat You Bring\n\n, • Mastery of Statistical Programming: Expert-level proficiency in SAS and data manipulation techniques, with knowledge of R/Python in a validated clinical environment.\n, • CDISC & Regulatory Standards: Thorough understanding of CDISC SDTM and ADaM models, Define.xml generation, and validation tools.\n, • Regulatory Filing Experience: Hands-on experience authoring submission-level deliverables and supporting major regulatory filings.\n, • Analytical & Problem-Solving Skills: Ability to resolve complex programming challenges and optimize data workflows.\n, • Cross-Functional Collaboration: Exceptional communication skills to collaborate effectively with various teams.\n, • Quality & GxP Compliance: Knowledge of ICH/GCP guidelines and standard operating procedures governing clinical reporting.\nEducation & Experience\n\n, • Bachelor’s, Master’s, or Ph.D. in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related field.\n, • Minimum of 8 years of statistical programming experience in the pharmaceutical, biotechnology, or CRO industry (or 6+ years with an advanced degree).\n, • Proven track record as the primary study or program lead programmer for multiple clinical studies.\n, • Direct experience supporting at least one major regulatory filing is strongly preferred.\nWhy Jazz?\n At Jazz, we believe in fair and equitable compensation practices. For this role, the base pay range is $138,400.00 - $207,600.00, depending on qualifications, skills, and experience. In addition to competitive base pay, you may also be eligible for: \n\n • Discretionary annual cash bonuses or incentive compensation.\n, • Discretionary equity grants.\n, • Comprehensive benefits offerings, including medical, dental, and vision insurance, a 401k retirement savings plan, and flexible paid vacation.\n\n Jazz Pharmaceuticals is an equal opportunity/affirmative action employer. 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. \n For US-Based Candidates Only: \n Jazz Pharmaceuticals, Inc. is committed to fair and equitable compensation practices. We strive to provide employees with total compensation packages that are market competitive.