Lead Clinical Statistical Programmer – SDTM/ADaM Expert

CSL Plasma Inc.; Thatcham; On-site; GBP 70,000 - 100,000; Full time

Job summary

CSL Seqirus in Maidenhead is seeking a Senior Clinical Statistical Programmer to take technical ownership of one or two trials from first line code to submission-ready packages. This hands-on role requires building and validating SDTM/ADaM datasets, TFLs and delivery of analysis outputs with regulatory scrutiny in mind.

You'll lead end-to-end programming, mentor junior staff, review CRO deliverables, and shape study analysis through protocols and SAPs, collaborating with statisticians, data

Qualifications

• Experience programming in pharmaceutical or clinical research settings.
• Strong SAS proficiency with regulatory submission experience.
• Knowledge of CDISC standards for SDTM/ADaM.
• Ability to interpret protocols and SAPs for dataset design.
• Experience collaborating with CROs and vendors on data delivery.

Responsibilities

• Lead end-to-end programming for assigned trials from setup to submission.
• Design and validate SDTM/ADaM datasets, tables, figures and listings.
• Review CRO-delivered deliverables for submission readiness.
• Mentor junior programmers and contribute to process improvements.
• Tackle ad hoc analyses and regulatory query responses as needed.

Skills

SAS programming

CDISC standards

Regulatory submissions

Mentor others

Stakeholder collaboration

Education

BSc in Computer Science, Mathematics, Statistics or related field

Tools

SAS

R

Job description

CSL Seqirus in Maidenhead is seeking a Senior Clinical Statistical Programmer to take technical ownership of one or two trials from first line code to submission-ready packages. This hands-on role requires building and validating SDTM/ADaM datasets, TFLs and delivery of analysis outputs with regulatory scrutiny in mind.

You'll lead end-to-end programming, mentor junior staff, review CRO deliverables, and shape study analysis through protocols and SAPs, collaborating with statisticians, data