
Ling Deng
Sr Director @ Kailera Therapeutics
About
Rich experience in clinical development planning, clinical trial design, and statistical analysis in multiple therapeutics; submission experiences for several successful NDA/sNDA/MAA. Management experience of statistician, statistical programming, and CRO. Well-organized project coordinator through careful planning. Self-motivated and strong leadership and ability for identifying issues, prioritizing and solving issues; influence clinical decision and optimize project timeline by using scientific intelligence and planning. Keen interest in statistical methodology and the application on clinical trials (missing data, sample size estimation and re-assessment, adaptive design, multiplicity adjustment, non-inferiority, external control and synthesis approach, disease progression model, Bayesian techniques, data visualization) and research ability including using advanced statistical simulation/modeling tool. Strong skills in SAS, R with extension skill of various packages, EAST.
United States
New York City Metropolitan Area
Pharmaceuticals
Regulatory Submissions, CDISC Standards, Regulatory Guidelines, Statistical Analysis Plans, Biometrics, SAS, R; EAST., Extensive experience of interactions with regulatory agencies as biostatistics lead for NDAs, MAAs or other regulatory submissions. , In-depth knowledge of regulations and guidelines, • In-depth knowledge of regulations and guidelines, Clinical Study Design, Biostatistics, SAS, R
Experience

Sr. Director Biostatistics
NJ
Role Project Phase Leading statistician Lurasidone pediatric program Phase III (schizophrenia, bipolar, and autistic disorder) Leading statistician Binge Eating Disorder program Phase II/III Leading statistician Bipolar I Disorder Phase III
Ling Deng's Contact Information
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