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, flexible vacation, health insurance, and opportunities for professional growth.
- Other info: Remote work options available with excellent career advancement opportunities.
- Why this job: Make a real impact in healthcare by transforming patients' lives through innovative therapies.
- 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.
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 in London 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 in London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Jazz Pharmaceuticals. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Jazz Pharmaceuticals.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Jazz Pharmaceuticals. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Jazz Pharmaceuticals is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Principal Statistical Programmer in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Jazz Pharmaceuticals!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Jazz Pharmaceuticals that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Jazz Pharmaceuticals!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Jazz Pharmaceuticals, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Jazz Pharmaceuticals
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Jazz Pharmaceuticals that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Jazz Pharmaceuticals’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
