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

Job description

Job DescriptionJoin Our Team as a Senior Clinical Statistical Programmer!

Are you ready to take your programming skills to the next level? At CSL, we’re on the lookout for a Senior Programmer who will play a pivotal role in our clinical trials. This is not just any programming position; you will have the technical ownership of one or two clinical trials from the very first line of code to the final submission package. If you’re passionate about ensuring data integrity and want to make a real impact, this is the role for you!

The Role

In this hands-on statistical programming role, you will be the go-to expert for your study team. You’ll collaborate closely with statisticians, data managers, medical writers, and regulatory colleagues, shaping how a study's analysis is structured right from the start. Your expertise will guide the creation of submission-ready SDTM and ADaM datasets, TFLs, and supporting documentation.

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

Why It Matters

Clinical data is only as valuable as the programming that supports it. Every regulatory decision—whether a safety signal is caught or missed—depends on the quality of the datasets and outputs. In this role, you will be at the heart of this critical process, ensuring that everything is built correctly from the outset. You won’t just execute specifications; you’ll often be the one writing them, identifying ambiguities in protocols before they become data issues.

Your Responsibilities

As a Senior Clinical Statistical Programmer, you will:

• Lead programming for your assigned studies, interpreting protocols, SAPs, data management plans, and CRF specifications.
• Design and validate SDTM and ADaM datasets, tables, figures, and listings in collaboration with study statisticians.
• Review and take ownership of CRO-produced deliverables, ensuring they meet submission-ready quality standards.
• Lead the specification and delivery of integrated analyses (e.g., ISS/ISE) and associated outputs when not handled by a CRO.
• Mentor less experienced programmers on internal processes and standards, contributing to departmental tools and process improvements.
• Engage in ad hoc analytical work, including regulatory query responses, exploratory analyses, and publication support as needed.

What We’re Looking For

To thrive in this role, you should have:

• 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 proven 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 is a bonus).
• Comfort in working with external vendors and CRO-managed data.
• A BSc in Computer Science, Mathematics, Statistics, or a related field; equivalent experience and certifications will also be considered.

Why Join Us?

At CSL, we believe in fostering a collaborative and innovative environment where your contributions truly matter. You’ll have the opportunity to grow your skills, mentor others, and make a significant impact on the future of clinical research. If you’re ready to take on this exciting challenge, we’d love to hear from you!

Extra information

Status

Open

Education Level

Secondary School

Location

reading

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