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

CSL; Normanton on Trent; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

CSL seeks a Senior Clinical Statistical Programmer to own one or two trials from data creation to submission. You’ll set data structures, validate outputs and ensure regulatory readiness, collaborating with statisticians, data managers and regulatory colleagues.

You will work in Maidenhead with hybrid on-site requirements, leading SDTM/ADaM development, TFLs and integrated analyses, while mentoring peers and reviewing CRO deliverables for compliance.

Qualifications

• Experience in pharmaceutical, biotech, CRO, or clinical research settings.
• Strong SAS proficiency; familiarity with R or similar language.
• Knowledge of CDISC standards: CDASH, SDTM, ADaM, define.xml.
• Experience producing submission-ready TFLs and datasets.
• Regulatory submissions experience (FDA required; EMA/PMDA a plus).
• Ability to work with CROs and external vendors.
• BSc or equivalent in relevant field.

Responsibilities

• Lead end-to-end programming for assigned studies — in‑house or outsourced — from setup through analysis, reporting and regulatory submission.
• Design and validate SDTM and ADaM datasets, tables, figures and listings with statisticians.
• Review CRO‑produced deliverables for submission-ready quality.
• Lead integrated analyses (ISS/ISE) when not CRO‑handled.
• Mentor junior programmers and contribute to tooling and processes.
• Handle ad hoc analytical work for regulatory queries and publications.

Skills

SAS Proficiency

CDISC standards

Mentoring

Education

BSc in CS/Math/Statistics

Tools

SAS (Base/Macro/Stat/Graph)

R familiarity

Job description

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

The Role

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

You'll lead end‑to‑end programming for your assigned studies — in‑house or outsourced — spanning the full clinical development lifecycle from study setup through analysis, reporting, and regulatory submission. That means building and validating datasets and outputs yourself where the work is done internally, and holding CRO‑delivered work to the same bar where it isn't. You'll also be a technical reference point for less experienced programmers, and a contributor to how the wider programming function does its work.

• 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 Required

• 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