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

CSL Plasma Inc.; Maidenhead; On-site; GBP 90,000 - 120,000; Full time

Job summary

CSL Plasma Inc. is seeking a Senior Clinical Statistical Programmer to own the programming for one or two trials from setup to submission, collaborating with statisticians, data managers and regulatory colleagues.

You will influence study analysis structures and ensure audit-ready outputs across SDTM/ADaM datasets, TFLs and supporting documents. The role is hybrid with three days on-site in Maidenhead, focusing on end-to-end programming and mentorship, shaping data handling, analysis, and

Qualifications

• Experience in pharmaceutical/biotech/CRO clinical research settings.
• Track record of producing submission-ready TFLs and datasets.
• Familiarity with CDISC standards (SDTM/ADaM/CDASH).
• Experience supporting regulatory submissions (FDA, EMA, etc.).
• Ability to mentor and guide other programmers.

Responsibilities

• Lead end-to-end programming for assigned studies from setup to submission.
• Design/validate SDTM and ADaM datasets, tables, figures, and listings.
• Review CRO-delivered outputs for submission-ready quality.
• Lead integrated analyses (e.g. ISS/ISE) when not handled by CRO.
• Mentor junior programmers and contribute to processes and tools.
• Handle ad hoc analyses and regulatory query responses.

Skills

SAS proficiency

R familiarity

Clinical programming

Data validation

Mentoring

Education

BSc in Computer Science/Mathematics/Statistics or related field

Tools

SAS Suite

CDISC standards (SDTM/ADaM/CDASH)

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