Experience

Elevar Therapeutics

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Director

  • Sep 2022 - Jan 2023

  Remote As the leading statistician worked on an NDA filing for rivoceranib in combination with camrelizumab as a first line treatment for hepatocellular carcinoma (HCC). Worked as the statistical representative in the strategy task force to explore indications and pathways to gain approvals for camrelizumab (an anti-PD-1 antibody, had been approved in mutilple indications in China) from NDA.



Kadmon, a Sanofi Company

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director of Biostatistics

  • Jan 2018 - Sep 2022

  Cambridge, Massachusetts As the only sponsor statistician involved in the whole life cycle of the pivot study ROCKstar, and secured the regulatory approval of REZUROCK™ (belumosudil) in July 2021. Acting as the only statistician for Kadmon covered all statistical tasks for clinical and medical affairs. Conducted study design, execution, reporting and publication for multiple clinical trials for two compounds on multiple indications.



Sanofi

• France
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract Statistician

  • Sep 2015 - Dec 2017

  Cambridge, MA Conducted statistical QC, reviewing FDA filing package for a biologic immunosuppressive product. Conducted multiple clinical trial study designs on rare diseases. Working on two FDA briefing books for two rare disease drugs.



AstraZeneca

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Statistical Scientist

  • Mar 2011 - May 2015

  Waltham, MA Conduct clinical statistics research and software implementation on topics of Oncology phase I dose finding, personalized oncology drug development strategy, adaptive design, group sequential design, multiple comparisons and tests. Develop and standardize translational and preclinical study reporting template and data package (right end points, right data presentation and interpretation, right statistical analyses, intuitive visualizations), improve the efficiency and effectiveness for… Show more Conduct clinical statistics research and software implementation on topics of Oncology phase I dose finding, personalized oncology drug development strategy, adaptive design, group sequential design, multiple comparisons and tests. Develop and standardize translational and preclinical study reporting template and data package (right end points, right data presentation and interpretation, right statistical analyses, intuitive visualizations), improve the efficiency and effectiveness for study teams to interpret and report translational and preclinical study results. Conduct biomarker data analyses to validate and qualify biomarkers for pre and early clinical studies. Design and deliver statistics review courses. Show less



Takeda Oncology

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Contract Statistician

  • Jan 2010 - Mar 2011

  Cambridge, MA Participated in phase I, II and III clinical trials for an anti-inflammatory compound. Responsible for assisting ISS and ISE planning, writing statistical analysis plans, writing table, figure, listing shells and data specifications, validating key efficacy and safety data, conducting QC on statistical results, performing simulation with blinded data to predict various study outcomes, and conducting simulation study regarding to regulatory agencies' inquiries to defend company's study design… Show more Participated in phase I, II and III clinical trials for an anti-inflammatory compound. Responsible for assisting ISS and ISE planning, writing statistical analysis plans, writing table, figure, listing shells and data specifications, validating key efficacy and safety data, conducting QC on statistical results, performing simulation with blinded data to predict various study outcomes, and conducting simulation study regarding to regulatory agencies' inquiries to defend company's study design and analysis strategies. Show less



Johnson & Johnson

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Contract Statistician

  • Sep 2009 - Jan 2010

  Titusville, NJ Conducted QC, interpreted and reported ISS analyses on multiple phase I to phase III clinical trials to support EU submission for a antipsychotic drug, reviewed clinical study report.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Manager

  • Nov 2007 - Jul 2009

  New London, CT Participated in multiple HIV clinical trials as a protocol statistician. Responsible for providing strategic, statistical and scientific inputs into study design, performing sample size and power calculations, writing statistical part of study protocols, writing statistical analysis plans and creating table, figure and listing shells, conducting statistical analyses, writing statistical reports, reviewing CSRs, responding to regulatory agencies to defend study design and answer their inquiries,… Show more Participated in multiple HIV clinical trials as a protocol statistician. Responsible for providing strategic, statistical and scientific inputs into study design, performing sample size and power calculations, writing statistical part of study protocols, writing statistical analysis plans and creating table, figure and listing shells, conducting statistical analyses, writing statistical reports, reviewing CSRs, responding to regulatory agencies to defend study design and answer their inquiries, and communicating with outsourcing partners and vendors. Conducted adaptive dose-ranging study for a Phase IIA HIV clinical trial. Using GE medical record database (100+ GB of volume) to compare treatment effects of different antibiotics for acute exacerbations of chronic bronchitis (AECB). Responsible for designing case extraction and validation strategies, integrating database and software systems, writing Oracle SQL codes to extract AECB cases, designing and writing case listing tool for case validation, conducting statistical analysis, supporting publication activities. Show less



Stony Brook University

• United States
• Higher Education
• 700 & Above Employee

• Biostatistician

  • Aug 2004 - Nov 2007

  Greater New York City Area Participated in two clinical trials (Early Manifest Glaucoma Trial, Correction of Myopia Evaluation Trial). Responsible for providing statistical analysis plans, conducting statistical analyses, evaluating, interpreting and reporting study results, supporting publication activities. Integrated and developed a set of R, SAS programs to improve efficiency for monitoring, reporting and presenting clinical trial results. Main focuses were to use more intuitive and standardized tables and… Show more Participated in two clinical trials (Early Manifest Glaucoma Trial, Correction of Myopia Evaluation Trial). Responsible for providing statistical analysis plans, conducting statistical analyses, evaluating, interpreting and reporting study results, supporting publication activities. Integrated and developed a set of R, SAS programs to improve efficiency for monitoring, reporting and presenting clinical trial results. Main focuses were to use more intuitive and standardized tables and figures, to modulize and standardize various statistical analysis and reporting functionalities, to automate data management and statistical reporting process. Participated as lecturer in the Biostatistics Course for the Clinical Research and Training Program attended by clinical research scholars and residents. Show less