At a Glance
- Tasks: Lead statistical programming for complex clinical trials and ensure high-quality data delivery.
- Company: Join Jazz Pharmaceuticals, a global biopharma innovating life-changing medicines.
- Benefits: Competitive salary, bonuses, flexible vacation, and comprehensive health benefits.
- Other info: Opportunity to mentor others and innovate within a supportive team.
- Why this job: Make a real impact in healthcare while advancing your career in a dynamic environment.
- Qualifications: Expertise in SAS and experience with regulatory submissions required.
The predicted salary is between 63000 - 77000 £ per year.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide.
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.
Principal Statistical Programmer employer: Jazz Pharmaceuticals
Jazz Pharmaceuticals is an exceptional employer, offering a dynamic work culture that prioritises innovation and collaboration in the biopharma industry. With a strong commitment to employee growth, we provide numerous opportunities for professional development and a competitive benefits package, including flexible paid vacation and comprehensive health insurance. Located in vibrant cities like London and Cambridge, our employees enjoy a stimulating environment that fosters creativity and teamwork while making a meaningful impact on patients' lives worldwide.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Statistical Programmer
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
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Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
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Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like Jazz Pharmaceuticals!
We think you need these skills to ace Principal Statistical Programmer
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Jazz Pharmaceuticals that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Jazz Pharmaceuticals.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Jazz Pharmaceuticals does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Jazz Pharmaceuticals
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Jazz Pharmaceuticals. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Jazz Pharmaceuticals's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Jazz Pharmaceuticals. This shows your passion for the industry!
