Senior Clinical Statistical Programmer (Portfolio Development Biometrics Programming)

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

The Role

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: youll 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. Youll 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 studys 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. Youre not just executing specifications; youre 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 studys analysis both scientifically sound and audit-ready.

What Youll Be Responsible For

Youll 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 isnt. Youll 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

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

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

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