Lead Clinical Statistical Programmer - End-to-End Trials

CSL

Reading

Hybrid

GBP 65,000 - 90,000

Full time

5 days ago

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Job summary

CSL is seeking a Senior Clinical Statistical Programmer to take technical ownership of one or two trials from study setup through final submission. This hands-on role requires shaping analysis datasets, validating outputs, and ensuring audit-ready submission-ready SDTM and ADaM datasets.

You'll work with statisticians, data managers, medical writers and regulatory colleagues, review CRO deliverables, mentor junior programmers, and contribute to cross-trial tooling and standards in a hybrid

Qualifications

Experience in pharmaceutical/biotech/CRO clinical research
Strong SAS proficiency; R familiarity a plus
Working knowledge of CDISC standards (CDASH/SDTM/ADaM)
Track record of submission-ready TFLs and datasets
Experience supporting regulatory submissions (FDA etc.)
Comfort working with CROs and external vendors

Responsibilities

Lead end-to-end programming for assigned studies, internal or CRO-delivered, from study setup to analysis and submission
Design and validate SDTM and ADaM datasets, tables, figures, listings with statisticians
Review CRO-delivered outputs to ensure submission-ready quality
Lead integrated analyses (e.g., ISS/ISE) when not handled by CRO
Mentor junior programmers and contribute to tooling and standards
Take on ad hoc analyses and regulatory query work as required