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

Job Description

Join Our Team as a Senior Clinical Statistical Programmer!\n

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 take technical ownership of clinical trials from the very first line of code to the final submission package. This is not just any programming role; it’s a hands-on position where your expertise will be pivotal in ensuring the integrity of clinical data.

The Role\n

In this dynamic position, you’ll be the go-to expert for your study team, ensuring that the data stands up to regulatory scrutiny. You’ll collaborate closely with statisticians, data managers, medical writers, and regulatory colleagues, shaping the analysis structure right from the start. Your contributions will lead to submission-ready SDTM and ADaM datasets, TFLs, and supporting documentation.

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

Why It Matters\n

Clinical data is only as reliable as the programming behind 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’ll be at the heart of that process, not just executing specifications but also crafting them. Your keen eye will catch ambiguities in protocols before they become data issues, ensuring that analyses are scientifically sound and audit-ready.

Your Responsibilities\n

As a Senior Clinical Statistical Programmer, you will:

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

To thrive in this role, you should have:

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

At CSL, we believe in fostering a culture of growth and collaboration. You’ll have the opportunity to:

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• Work in a supportive environment where your contributions are valued.
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• Engage in meaningful work that impacts patient lives.
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• Enjoy a flexible work schedule that promotes work-life balance.
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• Access continuous learning and development opportunities to advance your career.
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If you’re ready to make a significant impact in the world of clinical programming, we’d love to hear from you!