Principal Clinical Statistical Programmer (Portfolio Development / Biometrics / Programming)

CSL; Thatcham; Hybrid; GBP 90,000 - 130,000; Full time

Job summary

CSL Seqirus is seeking a Principal Programmer to take technical ownership of statistical programming across a programme, setting standards across multiple trials and through submission. This hands-on role writes and validates code while shaping analysis strategy with biostatistics, data management and regulatory leads, ensuring regulatory defensibility and consistency.

Hybrid based in Maidenhead: three days onsite, with the opportunity to influence programmes at scale within a global vaccines

Qualifications

• Substantial statistical programming experience across multiple studies.
• Lead programmer responsibility with influence over analyses and submission packages.
• Knowledge of CDISC standards (CDASH, SDTM, ADaM, define.xml) and applying them consistently.

Responsibilities

• Serve as lead programmer for a programme across multiple trials.
• Define programming strategy for integrated analyses (ISS/ISE) and submission-ready data packages.
• Lead and mentor other programmers and contribute to standards and tools.

Skills

SAS Proficiency

Lead Programmer

Statistical Programming

Regulatory Submissions

Education

BSc in Computer Science/Math/Stats

MSc desirable

Tools

SAS

R

Job description

The Role

The Role CSL is looking for a Principal Programmer to take technical ownership of statistical programming across a compound or programme, not just a single study. You’ll be the person who sets how the programming gets done across multiple trials and through to submission, and the one a study team, a CRO or a regulator’s question ultimately lands with. This is still a hands‑on role, and you’ll write and validate code when the work calls for it. Most of your impact, though, comes from the decisions upstream: how standards are applied across studies so an integrated analysis comes together cleanly, how CRO work is scoped and held to account, and how a submission package is built so it holds up under review. You’ll work as a peer to biostatistics, data management, medical writing and regulatory leads, and you’ll be in the room early enough to shape a programme’s analysis strategy rather than inherit it.

Hybrid Based (3 days a week onsite) in Maidenhead

Why It Matters

A single well-programmed study is valuable. A programme where every study was built to the same standard, so pooled safety and efficacy analyses come together without months of rework, is what gets a submission over the line. This role sits at that level. You spot the inconsistency between two studies’ ADaM conventions before it becomes an ISS problem, push back on a CRO deliverable that technically meets spec but won’t survive a reviewer, and make the call on the trade-offs between speed, consistency and regulatory defensibility. When an agency query comes back, you’re the one who knows why the data was built the way it was.

What You’ll Be Responsible For

• Serve as lead programmer for a compound or programme, overseeing programming across multiple clinical trials and ensuring consistency of standards and approach
• Lead the planning, specification and delivery of integrated analyses (ISS/ISE) and pooled datasets, and own the submission‑ready data package, including define.xml, reviewer guides (cSDRG/ADRG) and conformance checks
• Define programming strategy for outsourced studies, set expectations for CROs and hold their deliverables to submission standard
• Act as the programming point of contact for regulatory submissions and agency queries, working with biostatistics and regulatory colleagues on responses
• Lead and mentor other programmers, providing technical direction, review and day‑to‑day guidance across the programme
• Contribute to departmental standards, macros, tools and process improvement, including the adoption of new approaches such as R‑based workflows
• Take on hands‑on programming and ad hoc analytical work (exploratory analyses, publication support, regulatory responses) as the programme requires

Experience Required

Substantial statistical programming experience in pharmaceutical, biotech, CRO or clinical research settings, including lead programmer responsibility across multiple studies. Expert SAS proficiency (Base/Macro/Stat/Graph); working experience with R or other languages is a strong plus. Deep, practical knowledge of current CDISC standards (CDASH, SDTM, ADaM, define.xml) and how to apply them consistently across a programme. Track record of leading integrated analyses (ISS/ISE) and delivering submission‑ready data packages. Direct experience of supporting regulatory submissions end to end (FDA required; PMDA, NMPA or EMA experience a plus), include BSc in Computer Science, Mathematics, Statistics or a related field (MSc desirable); equivalent experience and certifications will also be considered.

About CSL Seqirus

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. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits For more information on CSL benefits visit How CSL Supports Your Well‑being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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Watch our ‘On the Front Line’ video to learn more about CSL Seqirus CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process.

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