At a Glance
- Tasks: Lead programming for clinical trials, ensuring data integrity and regulatory compliance.
- Company: Join CSL Seqirus, a global leader in influenza vaccine production.
- Benefits: Enjoy competitive benefits, including health support and a culture of inclusion.
- Other info: Hybrid work model with opportunities for mentorship and career growth.
- Why this job: Make a real impact on public health through trustworthy clinical data.
- Qualifications: Strong SAS skills and experience in clinical research required.
The predicted salary is between 63000 - 77000 £ per year.
CSL is looking for a Senior Programmer to take technical ownership of one or two clinical trials from first line of code to final submission package. This is a hands-on statistical programming role with real authority attached to it: you'll be the person a study team turns to when the data needs to hold up under regulatory scrutiny, and the person who decides how a dataset gets built, not just who builds it. You'll work alongside statisticians, data managers, medical writers and regulatory colleagues as a peer, not a downstream resource — reading protocols and SAPs early enough to shape how a study's analysis gets structured, then seeing that structure through to submission-ready SDTM and ADaM datasets, TFLs, and supporting documentation.
Why It Matters
Clinical data is only as useful as the programming behind it is trustworthy. Every regulatory decision downstream — every safety signal caught or missed, every submission accepted or queried — traces back to whether the datasets and outputs were built right the first time. This role sits at that pressure point. You're not just executing specifications; you're often the one writing them, catching the ambiguity in a protocol before it becomes a data problem three months later, and making the judgment calls that keep a study's analysis both scientifically sound and audit-ready.
What You'll Be Responsible For
- Lead end-to-end programming for your assigned studies — in-house or outsourced — spanning the full clinical development lifecycle from study setup through analysis, reporting, and regulatory submission.
- Build and validate datasets and outputs yourself where the work is done internally, and hold CRO-delivered work to the same bar where it isn't.
- Serve as lead programmer for one or two clinical trials, interpreting protocols, SAPs, data management plans, and CRF specifications to drive study setup and analysis.
- Design and validate SDTM and ADaM datasets, tables, figures, and listings, in partnership with study statisticians.
- Review and take ownership of CRO-produced deliverables, ensuring submission-ready quality before they go further.
- Lead specification and delivery of integrated analyses (e.g. ISS/ISE) and associated outputs when not handled by a CRO.
- Mentor other programmers on internal processes and standards, and contribute to departmental tools and process improvements.
- Take on ad hoc analytical work — regulatory query responses, exploratory analyses, publication support — as studies require it.
Experience Required
- Experience of programming in pharmaceutical, biotech, CRO, or clinical research settings.
- Strong SAS proficiency (Base/Macro/Stat/Graph); familiarity with R or other languages is a plus.
- Working knowledge of current CDISC standards — CDASH, SDTM, ADaM, define.xml.
- Track record of producing and validating submission-ready TFLs and datasets, including ad hoc analytical requests.
- Experience supporting regulatory submissions (FDA required; PMDA, NMPA, or EMA experience a plus).
- Comfort working with external vendors and CRO-managed data.
- BSc in Computer Science, Mathematics, Statistics or a related field — equivalent experience and certifications will also be considered.
Senior Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming) in Maidenhead employer: CSL Plasma
CSL Seqirus is an exceptional employer, offering a dynamic work environment that prioritises inclusion and belonging, making it a great place for professionals seeking to make a meaningful impact in the healthcare sector. With a strong focus on employee well-being, competitive benefits, and opportunities for growth within a global organisation, employees are empowered to thrive while contributing to vital health initiatives across the EMEA region. The hybrid work model further enhances work-life balance, allowing team members to collaborate effectively while enjoying flexibility in their roles.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming) in Maidenhead
✨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!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like CSL Plasma. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
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!
✨Stay Up-to-Date with Industry Trends
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 CSL Plasma!
We think you need these skills to ace Senior Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming) in Maidenhead
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 CSL Plasma 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 CSL Plasma.
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 CSL Plasma 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 CSL Plasma
✨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 CSL Plasma. 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 CSL Plasma'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 CSL Plasma. This shows your passion for the industry!
