Principal Statistical Programmer - ( Oncology )

Job DescriptionRole - Principal Programmer\n\nWe are hiring for a Principal Programmer with an expert in Oncology TA.\n\nTotal experience - 10 + years with 5+ years in Oncology TA\n\nRole requirement -\n\n Oncology-specific endpoints, like tumor response (e.g., RECIST criteria), progression-free survival, overall survival etc.\n Worked on RECIST, Kaplan-Meier curves, forest plots, Cox proportional hazards models, forest plots, log-rank tests etc., Biomarker or genomic data, if applicable\n Working and/or worked as Lead programmer on regulatory submissions (e.g., NDA, BLA, eCTD) and integrated summaries (ISS/ISE), submission-ready deliverables (e.g., define.xml, reviewer’s guides) etc.\n Created time-to-event datasets/outputs (e.g., Kaplan-Meier plots, log-rank tests, Cox models) for oncology endpoints (PFS, OS, ORR) etc.\n Experience in immuno-oncology, CAR-T, or combination therapies.\n Statistical Programming Lead (SPL) for one or more end-to-end oncology studies or programs\n Experience working on programming outputs compliant with FDA/EMA requirements.\n Generated specification, define.xml, annotated CRFs, and reviewer guides (aSDRG, cSDRG).\n Experience working on standardization and automation across studies or multiple Oncology indications\n\n\n