Senior Clinical Statistical Programmer - SDTM/ADaM Lead

CSL Vifor; Maidenhead; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

CSL Vifor in Maidenhead seeks a Senior Clinical Statistical Programmer to own one or two trials from first line of code to submission-ready package. You will design, validate SDTM/ADaM datasets and outputs, work with statisticians and data managers, and mentor junior programmers.

You will lead end-to-end programming across the study lifecycle, review CRO deliverables, and ensure audit-ready analyses and documentation for regulatory submission.

Qualifications

• Experience in pharmaceutical/biotech CRO clinical research settings.
• Strong SAS proficiency (Base/Macro/Stat/Graph) and data standards familiarity.
• Knowledge of CDISC SDTM/ADaM and define.xml.
• Track record of submission-ready TFLs and datasets.
• Experience supporting regulatory submissions.
• Comfort working with CROs and external vendors.

Responsibilities

• Lead end-to-end programming for assigned studies, internal or CRO work, from setup to analysis and submission.
• Design and validate SDTM/ADaM datasets and outputs with statisticians.
• Review CRO deliverables to ensure submission-ready quality.
• Mentor junior programmers and contribute to standards.
• Handle ad hoc analyses and regulatory query support.

Skills

SAS

CDISC standards

Regulatory submissions

Mentorship

Education

BSc in Computer Science/Math/Statistics or related field

Tools

R

SAS Base/Macro

Job description

CSL Vifor in Maidenhead seeks a Senior Clinical Statistical Programmer to own one or two trials from first line of code to submission-ready package. You will design, validate SDTM/ADaM datasets and outputs, work with statisticians and data managers, and mentor junior programmers.

You will lead end-to-end programming across the study lifecycle, review CRO deliverables, and ensure audit-ready analyses and documentation for regulatory submission.