Senior Clinical Statistical Programmer (PortfolioDevelopment/Biometrics/Programming) in Reading

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.

Hybrid Based (3 days a week onsite) in Maidenhead.

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

• You'll 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.
• That means building and validating datasets and outputs yourself where the work is done internally, and holding CRO-delivered work to the same bar where it isn't.
• You'll also be a technical reference point for less experienced programmers, and a contributor to how the wider programming function does its work.
• 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.