Senior Clinical Programmer Lead SDTM/ADaM & Submissions

CSL Seqirus Inc.; Taplow; Hybrid; GBP 70,000 - 110,000; Full time

Job summary

CSL Seqirus is seeking a Senior Programmer to own the technical delivery of one or two clinical trials from first line code through submission package. This hands-on role gives real authority to shape data structures, SDTM/ADaM outputs, and reports for regulatory review.

Hybrid base in Maidenhead (3 days on site). You will collaborate with statisticians, data managers, medical writers and regulatory colleagues, setting standards, mentoring programmers, and ensuring submission‑ready datasets and

Qualifications

• Lead programmer for one or two clinical trials, interpreting protocols, SAPs, data management plans, and CRF specifications to drive study setup and analysis.
• Design and validate SDTM and ADaM datasets, tables, figures, and listings, in partnership with study statisticians.
• Review and take ownership of CRO-delivered deliverables, ensuring submission-ready quality before they go further.
• Lead specification and delivery of integrated analyses (e.g. ISS/ISE) and associated outputs when not handled by a CRO.
• Mentor other programmers on internal processes and standards, and contribute to departmental tools and process improvements.
• Take on ad hoc analytical work - regulatory query responses, exploratory analyses, publication support - as studies require it.
• Experience of programming in pharmaceutical, biotech, CRO, or clinical research settings.
• Strong SAS proficiency (Base/Macro/Stat/Graph); familiarity with R or other languages is a plus.
• Working knowledge of current CDISC standards - CDASH, SDTM, ADaM, define.xml
• Track record of producing and validating submission-ready TFLs and datasets, including ad hoc analytical requests.
• Experience supporting regulatory submissions (FDA required; PMDA, NMPA, or EMA experience a plus).
• Comfort working with external vendors and CRO-managed data
• BSc in Computer Science, Mathematics, Statistics or a related field - equivalent experience and certifications will also be considered

Responsibilities

• Serve as lead programmer for one or two clinical trials, interpreting protocols, SAPs, data management plans, and CRF specifications to drive study setup and analysis
• Design and validate SDTM and ADaM datasets, tables, figures, and listings, in partnership with study statisticians
• Review and take ownership of CRO-produced deliverables, ensuring submission-ready quality before they go further
• Lead specification and delivery of integrated analyses (e.g. ISS/ISE) and associated outputs when not handled by a CRO
• Mentor other programmers on internal processes and standards, and contribute to departmental tools and process improvements
• Take on ad hoc analytical work - regulatory query responses, exploratory analyses, publication support - as studies require it

Skills

Lead programming ownership

Statistical programming

Regulatory understanding

Mentoring

Education

BSc in Computer Science, Mathematics, Statistics or related field

Tools

SAS (Base/Macro/Stat/Graph)

R

Job description

CSL Seqirus is seeking a Senior Programmer to own the technical delivery of one or two clinical trials from first line code through submission package. This hands-on role gives real authority to shape data structures, SDTM/ADaM outputs, and reports for regulatory review.

Hybrid base in Maidenhead (3 days on site). You will collaborate with statisticians, data managers, medical writers and regulatory colleagues, setting standards, mentoring programmers, and ensuring submission‑ready datasets and