Lead Clinical Statistical Programmer - Hybrid (Maidenhead)

CSL Plasma Inc.; Maidenhead; Hybrid; GBP 90,000 - 120,000; Full time

Job summary

CSL Plasma Inc. is seeking a Senior Clinical Statistical Programmer to own the programming for one or two trials from setup to submission, collaborating with statisticians, data managers and regulatory colleagues.

You will influence study analysis structures and ensure audit-ready outputs across SDTM/ADaM datasets, TFLs and supporting documents. The role is hybrid with three days on-site in Maidenhead, focusing on end-to-end programming and mentorship, shaping data handling, analysis, and

Qualifications

• Experience in pharmaceutical/biotech/CRO clinical research settings.
• Track record of producing submission-ready TFLs and datasets.
• Familiarity with CDISC standards (SDTM/ADaM/CDASH).
• Experience supporting regulatory submissions (FDA, EMA, etc.).
• Ability to mentor and guide other programmers.

Responsibilities

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

Skills

SAS proficiency

R familiarity

Clinical programming

Data validation

Mentoring

Education

BSc in Computer Science/Mathematics/Statistics or related field

Tools

SAS Suite

CDISC standards (SDTM/ADaM/CDASH)

Job description

CSL Plasma Inc. is seeking a Senior Clinical Statistical Programmer to own the programming for one or two trials from setup to submission, collaborating with statisticians, data managers and regulatory colleagues.

You will influence study analysis structures and ensure audit-ready outputs across SDTM/ADaM datasets, TFLs and supporting documents. The role is hybrid with three days on-site in Maidenhead, focusing on end-to-end programming and mentorship, shaping data handling, analysis, and