Lead Clinical Statistical Programmer - SDTM/ADaM Expert

CSL; Normanton on Trent; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

CSL seeks a Senior Clinical Statistical Programmer to own one or two trials from data creation to submission. You’ll set data structures, validate outputs and ensure regulatory readiness, collaborating with statisticians, data managers and regulatory colleagues.

You will work in Maidenhead with hybrid on-site requirements, leading SDTM/ADaM development, TFLs and integrated analyses, while mentoring peers and reviewing CRO deliverables for compliance.

Qualifications

• Experience in pharmaceutical, biotech, CRO, or clinical research settings.
• Strong SAS proficiency; familiarity with R or similar language.
• Knowledge of CDISC standards: CDASH, SDTM, ADaM, define.xml.
• Experience producing submission-ready TFLs and datasets.
• Regulatory submissions experience (FDA required; EMA/PMDA a plus).
• Ability to work with CROs and external vendors.
• BSc or equivalent in relevant field.

Responsibilities

• Lead end-to-end programming for assigned studies — in‑house or outsourced — from setup through analysis, reporting and regulatory submission.
• Design and validate SDTM and ADaM datasets, tables, figures and listings with statisticians.
• Review CRO‑produced deliverables for submission-ready quality.
• Lead integrated analyses (ISS/ISE) when not CRO‑handled.
• Mentor junior programmers and contribute to tooling and processes.
• Handle ad hoc analytical work for regulatory queries and publications.

Skills

SAS Proficiency

CDISC standards

Mentoring

Education

BSc in CS/Math/Statistics

Tools

SAS (Base/Macro/Stat/Graph)

R familiarity

Job description

CSL seeks a Senior Clinical Statistical Programmer to own one or two trials from data creation to submission. You’ll set data structures, validate outputs and ensure regulatory readiness, collaborating with statisticians, data managers and regulatory colleagues.

You will work in Maidenhead with hybrid on-site requirements, leading SDTM/ADaM development, TFLs and integrated analyses, while mentoring peers and reviewing CRO deliverables for compliance.