Norma Guzman-Becerra, M.S.
Founder & Biostatistician
NGB Biostatistics and Programming Consulting LLC
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Founder & Biostatistician
NGB Biostatistics and Programming Consulting LLC
Download Full CVFounder of NGB Biostatistics and Programming Consulting LLC with over 20 years of experience as a Director of Biostatistics. Proven track record leading statistical strategy for global clinical development programs across all phases (Phases 1–4), regulatory submissions (FDA, EMA, Health Canada, PMDA, TGA), and successful indication approvals including EBVALLO, ADVATE, and FEIBA.
Comprehensive review of study protocols and development of Statistical Analysis Plans (SAPs)
Statistical design support including power calculations and sample size determination
Creation of TFL shells, programming specifications, and ADaM dataset specifications
Independent SAS programming and validation of datasets and TFLs
Preparation of responses to regulatory agencies and biostatistics representation in meetings
Clinical development strategy, protocol review, and regulatory guidance