Senior Clinical Statistical Programmer (Portfolio Development / Biometrics /Programming)

Job description

The Role

Are you ready to take the reins of clinical trials from the very first line of code to the final submission package? At CSL, we’re on the lookout for a Senior Programmer who will play a pivotal role in ensuring the integrity and reliability of our clinical data. This is not just any programming position; you’ll be the go-to expert for study teams, ensuring that our datasets withstand regulatory scrutiny and are built with precision.

Location: Hybrid (3 days a week onsite) in Maidenhead

In the world of clinical research, the quality of our data is only as strong as the programming behind it. Every regulatory decision—whether it’s a safety signal caught or a submission accepted—hinges on the robustness of our datasets. In this role, you’ll be at the heart of it all, not just executing specifications but also crafting them. Your insights will help catch ambiguities before they escalate into data issues, ensuring that our analyses are scientifically sound and audit-ready.

As the lead programmer for your assigned studies, you’ll oversee the entire clinical development lifecycle, from study setup to regulatory submission. Here’s what you’ll be doing:

• Lead programming efforts for one or two clinical trials, interpreting protocols, SAPs, and data management plans to drive study setup and analysis.
• Design and validate SDTM and ADaM datasets, tables, figures, and listings in collaboration with study statisticians.
• Review and ensure the quality of CRO-produced deliverables, making sure they are submission-ready.
• Lead the specification and delivery of integrated analyses (e.g., ISS/ISE) and associated outputs when not managed by a CRO.
• Mentor junior programmers on internal processes and contribute to departmental tools and process improvements.
• Engage in ad hoc analytical work, including regulatory query responses and publication support as needed.

To thrive in this role, you should bring the following experience and skills:

• Proven experience in programming within pharmaceutical, biotech, CRO, or clinical research settings.
• Strong proficiency in SAS (Base/Macro/Stat/Graph); familiarity with R or other programming languages is a plus.
• Working knowledge of current CDISC standards (CDASH, SDTM, ADaM, define.xml).
• A track record of producing and validating submission-ready TFLs and datasets, including handling ad hoc analytical requests.
• Experience supporting regulatory submissions (FDA experience required; PMDA, NMPA, or EMA experience is a bonus).
• Comfort in collaborating with external vendors and managing CRO data.
• A BSc in Computer Science, Mathematics, Statistics, or a related field; equivalent experience and certifications will also be considered.

At CSL, you’ll be part of a dynamic team that values innovation, collaboration, and professional growth. We offer a supportive environment where your contributions make a real impact. If you’re ready to elevate your career and help shape the future of clinical research, we want to hear from you!

Extra information

Status

Open

Education Level

Secondary School

Location

maidenhead

Type of Contract

Full-time jobs

Published at

06-11-2026

Profession type

Health / Medical

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English