Guohua Wen is a senior biostatistics leader with over a decade of experience designing and delivering statistical solutions for Phase I–III clinical trials and regulatory submissions. Currently managing biostatistics teams at AbbVie after leadership roles at Cerevel and Cytel, he blends deep SAS programming and CDISC expertise with hands-on oversight of submission-ready TLFs and 21 CFR Part 11–compliant documentation. Known for fast turnaround on complex analyses, he also directs resource planning, budgeting, and quality control to ensure ICH-GCP–aligned outputs. With an MPH in Biostatistics and a background spanning academic research to industry CROs, he brings both rigorous methodological grounding and practical operational discipline. An understated strength is his track record of translating protocol-level design decisions into auditable statistical plans and validated code that smooth FDA/NDA reviews.
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