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Sutan Wu

Mathematical Statistician

Mathematical Statistician at FDA

Gaithersburg, Maryland

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Sutan Wu's Work Experience


Mathematical Statistician

Silver Spring


Principal Statistics Consultant

Greater St. Louis Area

Bristol-Myers Squibb

Biostatistics Consultant

May 2012 to October 2013

Lawrenceville, New Jersey

Sutan Wu's Education

Florida State University

Ph.D, Statistics

2005 to 2010

University of Science and Technology of China

B.S, Applied Mathematics

2001 to 2005

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About Sutan Wu

📖 Summary

Mathematical Statistician @ FDA Silver SpringPrincipal Statistics Consultant @ SutanStats Serving Statistics Expert for multiple Generic Companies, Specialty Pharms and Diagnostics Lab from their pre-clinical discovery, early phase studies, pivotal studies to post-marketing promotion studies, including Process Development/CMC areas:Clinical Consulting Activities:1. Provide statistics insights and guidance for entire generic drug R&D and regulatory submissions via designing and analyzing multiple types PK/PD BA/BE studies and Pivotal Clinical BE studies;2. Provide statistics guidance/analysis on Human Abuse Potential Studies (HAP) for Abuse-Deterrence Opioid Products (pain management) and related CNS drugs;3. Design Phase IV studies to identify new indications and to promote the client’s product(s);4. Provide stat inputs on the interactions with agency such as addressing the response letter(s), preparing the sponsor meeting materials, and conducting the required ad-hoc analysis for ISS/ISE; 5. Provide statistics design and analysis on NGS based Laboratory Diagnostics Test;6. Lead the in-house programmers on ADaM specs and TLF programing; Supervise the CRO on SAP, TLF shells and ADaM/SDTM data specs;7. Solve complex statistical issues via statistics modeling/simulations such as Phase 3 design issues/data quality issues in international trial;8. Provide stat insights on agency's interactions (such as response letters);9. Conduct ad-hoc analysis for HEOR studies for pain medications and AEDs. Pre-clinical, Process Development, CMC Consulting Activities:1. Design and analyze the most appropriate and efficient Experiments for formulation and process space optimization;2. Help clients to implement "QbD" into the formulation and process;3. Design and analyze the stability study, spec setting and method transfer studies;4. Design and analyze the validation study for NGS-based diagnostics assay;5. Prepare the IND packages and serving as the Stat "Gatekeeper" for Quality, Animal Models and Toxicology Sections (M3 and M4), NDA package. Greater St. Louis AreaBiostatistics Consultant @ Bristol-Myers Squibb 1. Provide statistics analyses such as sample size calculation, repeated measures, mixed model, and linear/non-linear regressions to animal model studies/clinical laboratory studies in Cardiovascular and Metabolic Disease area/Virology area2. Design experiments and build regression models to support drug formulation and bio-analytical/analytical process development and optimization.3. Serve as the statistics consultant for pharmaceutical development function and educate scientists/engineers from the basic descriptive statistics to the sophisticated stat models4. Support animal toxicology studies for drug safety evaluation5. Assist biologists/bioinformatician on gene-expression data6. Provide stability analysis, shelf life determination and specs setting From May 2012 to October 2013 (1 year 6 months) Lawrenceville, New JerseyApplied Mathematician @ Roche Diagnostics Medical Device area Performed design of experiments, analysis of (co)variance, regression analyses and simulations to support the development and validation of blood glucose diagnostics and monitoring device.Implemented non-linear regression and mathematical optimization to fit calibration curve with Roche diagnostics math function.Designed experiments and statistical modeling to characterize current chemical/mechanic processes, find important factors, optimize current processes and continue model monitoring.Statistics quality control and investigate out-of-specification case with data mining tools (PCA, PLS, DA, etc.), variance component analysis(ANOVA/ANCOVA) and experiment designs.Modified a single acceptance-sampling plan to double acceptance sampling plan to reduce the operation cost and time. From December 2009 to February 2012 (2 years 3 months) Indianapolis, IndianaStatistics Consultant @ Florida State University Assist in the design or evaluation of experiments and sampling procedures: e.g. Factorial design, Random sampling and Sample size computationAssist in the interpretation and presentation of statistical resultsAdvise on the choice of statistical models and computer programs: From October 2007 to December 2009 (2 years 3 months) Tallahassee, FloridaStatistics Intern @ Johnson & Johnson -- Apply current competing risks analysis methods in a Phase III trial---Compute the sequential p-value for the interim analysis From June 2009 to September 2009 (4 months) Titusville, New JerseyStatistics Intern @ Medical College of Wisconsin Radiation Oncology Department-- Review the protocol, trial design, sample size calculation and data analysis (e.g. ANOVA, repeated measure) From June 2008 to August 2008 (3 months) Milwaukee, WisconsinMathematical Statistician @ FDA . Generic Drug statistics reviewer: Review/evaluate study protocol, statistics analysis plan (SAP), Pivotal Bioequivalence Study (such as all types of PK/PD study, and Clinical BE study) or Pivotal Non-inferiority Study;. CMC statistics reviewer: Review the CMC statistics related issues among the IND, NDA and ANDA submission and post-marketing changes, which include (bio)assay development and validation, pharmaceutical quality study, process optimization, manufacturing/process monitoring and control study;. Attend pre-IND, pre-NDA (industry), sponsor requested meetings (Type A- Type C) to discuss potential statistical issues in protocol design, and corresponding statistical analysis. Conduct research in in-vitro dissolution profile comparison, and analytical similarity evaluation for biosimilar products. From October 2013 to September 2014 (1 year) Silver Spring, Maryland

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Introversion (I), Intuition (N), Thinking (T), Judging (J)

Average Tenure

1 year(s), 3 month(s)

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