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Experienced Biostatistician with 25 years successful experience in clinical development, directing the statistical aspects of phase 1-4 clinical trials, and expert in process and quality management. • Created successful submission packages for health authorities in US, EU and Japan. Designed and ran studies with innovative statistical methodology. • Provided the statistical perspective in cross-functional teams working on process improvement. • Involved in outsourcing work to Africa, India and Europe, participated in audits in Australia and Europe. Well-organised, thorough, detail-oriented, structured and disciplined, analytical, makes complexity manageable and understandable, collaborative, good team player, strong programming skills including SAS.
BSc Maths & Stats, MSc Biometry, PhD Medical Stats, 25 years working in clinical development.
Infertility Research, Statistical Research, Process Management, Quality Management, Outsourcing. Standards, Regulatory Guidances, People Management, Cross-Cultural Experience, Computing skills.