Lead Clinical Statistical Programmer — Submissions-Ready Data

CSL; Maidenhead; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

CSL is seeking a Senior Clinical Statistical Programmer to own one or two trials from first line code to submission packaging. You’ll shape study analysis, write protocols, and ensure audit-ready datasets and TFLs for regulatory submissions.

You’ll lead end-to-end programming, mentor other programmers, and collaborate with statisticians, data managers, and regulatory teams in a hybrid Maidenhead setting.

Qualifications

• Experience in pharmaceutical/biotech/CRO clinical research.
• SAS proficiency (Base/Macro/Stat/Graph); R is a plus.
• CDISC standards knowledge: CDASH/SDTM/ADaM/define.xml.
• Track record of submission-ready TFLs and datasets.
• Experience supporting regulatory submissions (FDA; EMA a plus).
• Comfort working with external vendors and CROs.
• Degree or equivalent in a relevant field.

Responsibilities

• Lead end-to-end programming for assigned studies from setup to submission.
• Design and validate SDTM and ADaM datasets, tables, listings, figures.
• Review CRO-delivered outputs for submission-ready quality.
• Lead integrated analyses (e.g. ISS/ISE) when not via CRO.
• Mentor other programmers and contribute to tools/processes.
• Handle ad hoc analyses and regulatory query responses as needed.

Skills

SAS programming

CDISC standards

Regulatory submissions

Mentoring

Analytical thinking

Education

BSc in CS/Math/Stats

Tools

SAS Base/Macro

R

SQL

Job description

CSL is seeking a Senior Clinical Statistical Programmer to own one or two trials from first line code to submission packaging. You’ll shape study analysis, write protocols, and ensure audit-ready datasets and TFLs for regulatory submissions.

You’ll lead end-to-end programming, mentor other programmers, and collaborate with statisticians, data managers, and regulatory teams in a hybrid Maidenhead setting.