Senior Statistical Programmer

Key Requirements: 10+ years of statistical programming experience, including 5+ years within Oncology Strong 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 plots Experience working with biomarker and/or genomic data Experience in immuno-oncology, CAR-T and/or combination therapies Previous experience acting as Statistical Programming Lead (SPL) for end-to-end Oncology studies or programmes Strong regulatory submission experience, including NDA, BLA, eCTD, ISS/ISE and submission-ready deliverables Experience producing and reviewing CDISC-compliant datasets and documentation, including SDTM, ADaM, Define. xhqgsiq xml, annotated CRFs and reviewer guides (aSDRG/cSDRG)Experience developing time-to-event datasets and outputs for Oncology endpoints Strong understanding of FDA and EMA requirements for statistical programming and regulatory submissions Experience with standardisation and automation across studies and/or multiple Oncology indications If 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.