Senior Statistical Programmer

I’m currently supporting a clinical-stage organisation with the search for an experienced Principal Statistical Programmer with strong Oncology experience.This is a senior, hands-on contract opportunity for a programmer who has led programming activities across late-stage Oncology studies and regulatory submissions.Key Requirements10+ years of statistical programming experience, including 5+ years within OncologyStrong experience with Oncology endpoints including RECIST, ORR, PFS and OSHands-on experience with Kaplan-Meier curves, Cox proportional hazards models, log-rank tests and forest plotsExperience working with biomarker and/or genomic dataExperience in immuno-oncology, CAR-T and/or combination therapiesPrevious experience acting as Statistical Programming Lead (SPL) for end-to-end Oncology studies or programmesStrong regulatory submission experience, including NDA, BLA, eCTD, ISS/ISE and submission-ready deliverablesExperience producing and reviewing CDISC-compliant datasets and documentation, including SDTM, ADaM, Define.xml, annotated CRFs and reviewer guides (aSDRG/cSDRG)Experience developing time-to-event datasets and outputs for Oncology endpointsStrong understanding of FDA and EMA requirements for statistical programming and regulatory submissionsExperience with standardisation and automation across studies and/or multiple Oncology indicationsIf you have the required Oncology experience and are available for contract work, please get in touch with an up-to-date CV/resume and details of your availability.