• 16 years of clinical biostatistician experience in rare diseases (blood disorders, pulmonary disease) and oncology across all phases of clinical development (from IND to market access)• Experience with regulatory submission as well as interactions with FDA/EMA• Excellent resource planning and CRO management skills.
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Vp, BiometricsNeumora May 2021 - May 2023• Head of biometrics (including biostatistics, statistical programming and data management) to support company pipeline's clinical development -
Director Of BiostatisticsVertex Pharmaceuticals Aug 2018 - May 2021• Biostatistics Group Lead of CF portofolio including Phase IIIb/VI studies, HTA submission for reimbursement, and HEOR/RWE projects. -
Associate Director/Director Of BiostatisticsAgios Pharmaceuticals Sep 2013 - Aug 2018• Biostatistics Group Lead of Rare Disease Portfolio (beta-thalassemia, sickle cell disease, pyruvate kinase deficiency).• Built the rare disease biostat group and and responsible for CRO vendor assessment/selection. -
Senior Principal Statistician - OncologyTakeda Oncology Jun 2009 - Sep 2013• Biostatistics Lead of an oncology program (Ixazomib: an oral proteasome inhibitor for multiple myeloma and amyloidosis) including NDA/MAA submissions. -
Research Scientist - OncologyEli Lilly And Company Feb 2007 - Jun 2009Project Lead Statistician: led two monoclonal antibody compounds for supportive oncology treatments (anemia in multiple myeloma cancer patients; decreased muscle strength in pancreatic cancer patients)Supported Phase 1-3 oncology clinical trials for Alimta and Enzastaurin (multiple myeloma, acute myeloid leukemia, lung cancer, glioma, etc.)
Dave L Education Details
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Biostatistics
Frequently Asked Questions about Dave L
What is Dave L's role at the current company?
Dave L's current role is VP, Biometrics.
What schools did Dave L attend?
Dave L attended Nanjing University.
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Dave Gale
Experienced Manager With Proven Leadership Skills, Flexible To Most Any Situation. Contact Me At Dgalegp54@Gmail.ComGrove City, Oh3gmail.com, gmail.com, wescodist.com2 +161483XXXXX
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