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
- 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 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
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is 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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