Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)

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 is looking for a Senior Programmer to take technical ownership of one or two clinical trials from first line of code to final submission package. This is a hands‑on statistical programming role with real authority attached to it: you'll be the person a study team turns to when the data needs to hold up under regulatory scrutiny, and the person who decides how a dataset gets built, not just who builds it. You'll work alongside statisticians, data managers, medical writers and regulatory colleagues as a peer, not a downstream resource - reading protocols and SAPs early enough to shape how a study's analysis gets structured, then seeing that structure through to submission‑ready SDTM and ADaM datasets, TFLs, and supporting documentation.

Hybrid Based (3 days a week onsite) in Maidenhead

Why It Matters

Clinical data is only as useful as the programming behind it is trustworthy. Every regulatory decision downstream - every safety signal caught or missed, every submission accepted or queried - traces back to whether the datasets and outputs were built right the first time. This role sits at that pressure point. You're not just executing specifications; you're often the one writing them, catching the ambiguity in a protocol before it becomes a data problem three months later, and making the judgment calls that keep a study's analysis both scientifically sound and audit‑ready.

What You'll Be Responsible For

• 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
• 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

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state‑of‑the‑art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.