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

behind it. Every regulatory decision-whether it’s a safety signal caught or missed-depends on the quality of the datasets and outputs. In this role, you will be at the heart of this process, ensuring that everything is built right the first time. Your insights will help catch ambiguities early, preventing potential data issues down the line.Your ResponsibilitiesAs a Senior Clinical Statistical Programmer, you will: Lead end-to-end programming for your assigned studies, overseeing the full clinical development lifecycle from setup to regulatory submission. Design and validate SDTM and ADaM datasets, tables, figures, and listings in collaboration with study statisticians. Review and take ownership of CRO-produced deliverables, ensuring they meet submission-ready quality standards. Lead the specification and delivery of integrated analyses (e.g., ISS/ISE) and associated outputs when not handled by a CRO. Mentor less experienced programmers on internal processes and contribute to

departmental tools and process improvements. Engage in ad hoc analytical work, including regulatory query responses, exploratory analyses, and publication support as needed.What We’re Looking ForTo thrive in this role, you should have: Experience in programming within pharmaceutical, biotech, CRO, or clinical research settings. Strong proficiency in SAS (Base/Macro/Stat/Graph); familiarity with R or other programming languages is a plus. A working knowledge of current CDISC standards-CDASH, SDTM, ADaM, define.xml. A proven 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 is a bonus). Comfort in working with external vendors and CRO-managed data. A BSc in Computer Science, Mathematics, Statistics, or a related field; equivalent experience and certifications will also be considered.Why Join Us?At CSL, we believe in fostering a collaborative and innovative environment where your contributions truly matter. You’ll have the opportunity to grow your skills, mentor others, and make a significant impact on clinical trials that can change lives. If you’re ready to take on this challenge, we’d love to hear from you!

Job DescriptionJoin Our Team as a Senior Clinical Statistical Programmer!Are you ready to take your programming skills to the next level? At CSL, we are on the lookout for a Senior Programmer who will take technical ownership of one or two clinical trials, guiding them from the first line of code to the final submission package. This is not just any programming role; it’s a hands-on position where your expertise will be crucial in ensuring the integrity of clinical data.The RoleIn this pivotal role, you will be the go-to person for the study team when it comes to ensuring that data withstands regulatory scrutiny. You won’t just be executing specifications; you’ll be shaping them! Collaborate with statisticians, data managers, medical writers, and regulatory colleagues as a peer, influencing how a study’s analysis is structured and ensuring that it is submission-ready.Location: Hybrid (3 days a week onsite) in MaidenheadWhy It MattersClinical data is only as reliable as the programming