Cong Han Email and Phone Number
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More than twenty years of pharmaceutical industry experience in the design, analysis, and evaluation of clinical development programs and clinical trials in multiple therapeutic areas (gastroenterology, cardio-renal and metabolic diseases, women’s health, infectious diseases, neurologic and muscular disorders) and across modalities of small molecules, monoclonal antibodies, vaccines, gene therapies, and cell therapiesExtensive experience interacting with FDA, EMA, and other regulatory agencies (e.g., Health Canada, SwissMedic, Australia TGA, and (co-)rapporteurs)Participation (as company representative) in two PhRMA Limited-Duration Key Issue Teams (adaptive designs and non-inferiority)
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Vice President; Head Of Clinical BiometricsAstellas PharmaFairfax, Va, Us
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Executive Director, Biostatistics; Head Of Statistical Science, Cell & Gene TherapyAstellas Pharma Apr 2023 - PresentLead statistical support for cell and gene therapy programs for non-oncology indications; manage statistical support for programs with other treatment modalities for non-oncology indications (BioPharma) -
Senior Biostatistics DirectorAstellas Pharma Mar 2022 - Mar 2023Supported multiple projects in gene therapies and in the area of "software as a medical device"
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Biostatistics DirectorAstellas Pharma Mar 2021 - Mar 2022Supported multiple projects in the Medical Specialty therapeutic area, in gene therapies, and in "software as a medical device"; led Center for Innovative Statistics
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Senior Director, BiostatisticsNovartis Gene Therapies Mar 2020 - Mar 2021Basel, Baselstadt, ChAs Head of Analytics within Clinical Development and Analytics, led statistical support for a gene therapy for spinal muscular atrophy; supported due diligence projects in gene therapies for rare neurologic disorders -
Director, BiostatisticsAstellas Pharma Jul 2018 - Mar 2020Supported multiple projects in Medical Specialty therapeutic area including anemia associated with chronic kidney disease (esp. cardiovascular outcomes) and other causes, and hearing loss; supported due diligence projects in anti-infective area; co-led Center for Innovative Statistics
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Senior Director; Statistics Ta Head, Gastroenterology And VaccinesTakeda Aug 2016 - Jul 2018Tokyo, JpAs Statistics TA Head for two therapeutic areas, Gastroenterology and Vaccines, led statistical support for gastroenterology development programs, including Crohn’s disease, ulcerative colitis, gastroparesis, celiac disease, intestinal graft-vs-host disease, as well as vaccine development programs, including norovirus vaccine, dengue virus vaccine, polio vaccine, and Zika virus vaccineServed as a core member of Statistics Review Forum (cross-TA review of study designs and development programs), a member of Vaccine Synopsis and Protocol Review Committee, and a member of Gastroenterology Synopsis and Protocol Review BoardRepresented Statistics function in NeuroScience portfolio review with the FDA -
Director; Statistics Ta Head, VaccinesTakeda Nov 2014 - Aug 2016Tokyo, JpLed statistical support for vaccine development programs including norovirus vaccine, dengue virus vaccine, polio vaccine, and provided consultation on a regional program in influenza vaccineServed as a core member of Statistics Review Forum and a member of Vaccine Synopsis and Protocol Review Committee
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Associate Director, StatisticsTakeda May 2013 - Nov 2014Tokyo, JpSupported multiple projects in General Medicine (gastroenterology) therapeutic area including Crohn's disease, ulcerative colitis, primary sclerosing cholangitis, and irritable bowel syndrome (D)
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Senior Manager, StatisticsTakeda Mar 2010 - May 2013Tokyo, JpSupported multiple projects in General Medicine (gastroenterology and women’s health) and Cardiovascular/Metabolic therapeutic areas, including erosive esophagitis, gastroesophageal reflux disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome (D), gastric ulcer, duodenal ulcer, H. pylori eradication, menorrhagia, non-alcoholic steatohepatitis, diabetic nephropathy, acute coronary syndrome, acute heart failure, T1DM, obesity, as well as cardiovascular outcomes studies, some of which were joint projects with alliance partnersProvided statistical input to the Beta Cell Project of the Foundation for the National Institutes of Health Biomarkers Consortium
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Principal StatisticianTakeda Nov 2008 - Mar 2010Tokyo, JpSupported multiple projects in Gastroenterology therapeutic area including erosive esophagitis, gastroesophageal reflux disease, Crohn's disease, and ulcerative colitisRepresented Takeda on PhRMA Limited-Duration Key Issue Team (LDKIT) on Adaptive Designs and LDKIT on Non-Inferiority to respond to FDA draft guidance documents
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Project StatisticianTakeda Jul 2008 - Nov 2008Tokyo, JpSupported multiple projects in Gastroenterology therapeutic area including erosive esophagitis and gastroesophageal reflux disease
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Senior StatisticianTakeda Mar 2005 - Jun 2008Tokyo, JpAs a senior statistician at TAP (Takeda-Abbott Project) Pharmaceutical Products, Inc., supported development projects in gastroenterology and women’s health including erosive esophagitis and uterine fibroids
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Statistician IiTakeda Aug 2003 - Mar 2005Tokyo, JpAs a statistician at TAP Pharmaceutical Products, Inc., supported development projects in gastroenterology and women’s health including erosive esophagitis and uterine fibroids
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Assistant Professor Of BiostatisticsUniversity Of Washington Aug 2002 - Jul 2003Seattle, Wa, UsProvided statistical support to Multi-Ethnic Study of Atherosclerosis (MESA) and taught a graduate level course in linear regression to first year MS and PhD students in Biostatistics -
Lecturer Of Child And Adolescent HealthPeking University Health Science Center Apr 1992 - Jul 1995CnConducted research in adolescent mental health and problem behavior
Cong Han Skills
Cong Han Education Details
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University Of MinnesotaBiostatistics (Minor: Statistics) -
University Of MinnesotaBiological Psychopathology
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University Of Chinese Academy Of SciencesIndustrial Psychology
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Peking UniversityPsychology
Frequently Asked Questions about Cong Han
What company does Cong Han work for?
Cong Han works for Astellas Pharma
What is Cong Han's role at the current company?
Cong Han's current role is Vice President; Head of Clinical Biometrics.
What is Cong Han's email address?
Cong Han's email address is co****@****inc.com
What schools did Cong Han attend?
Cong Han attended University Of Minnesota, University Of Minnesota, University Of Chinese Academy Of Sciences, Peking University.
What skills is Cong Han known for?
Cong Han has skills like Clinical Development, Clinical Trials, Drug Development, Sas, Vaccines, Diabetes, Clinical Research, Pharmaceutical Industry, Design Of Experiments, R, Oncology, Statistics.
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