Machine Learning Clinical Trial

MEISHUO OUYANG

Postdoctoral Associate, Duke University School of Medicine, Durham, NC 27710

*******.******@****.***

LinkedIn: https://www.linkedin.com/in/meishuo-ouyang/ · Phone: 919-***-**** Postdoctoral Associate at Duke University with extensive experience in analyzing large medical datasets

(e.g., Medicare, SEER, NCDB) and clinical trial data to evaluate therapeutic outcomes, predict patient benefits, and assess adverse event profiles. Familiar with Phase I and II clinical trial design methodologies and FDA requirements, including clinical guidelines, statistical method selection, and sample size calculation. Proficient in advanced statistical methods, machine learning, and study design, including SAP drafting, RWE projects, and survival analysis. Fluent in English, Japanese (N1), and Chinese. Seeking to advance evidence-based healthcare through data-driven research and clinical impact. EXPERIENCE

2023 - PRESENT

POSTDOCTORAL ASSOCIATE, DUKE UNIVERSITY SCHOOL OF MEDICINE Clinical Trial Design and Statistics: Experienced in the design and statistical analysis of Phase I and Phase II clinical trials, with a strong understanding of FDA regulatory requirements and clinical guidelines. Proficient in selecting appropriate statistical methods, sample size estimation, and trial endpoints. Familiar with advanced trial designs, including adaptive designs, dose-escalation

(e.g., 3+3, continual reassessment method), and dose-expansion strategies. Contributed to the design and statistical planning of multiple early-phase RCTs for both hematologic malignancies and solid tumors.

Medicare Data Analysis: Applied counterfactual frameworks to assess clinical and social determinants of cardiovascular diseases (CVD), cancer, and Alzheimer’s disease (AD), integrating geographic-level confounding adjustments to evaluate disease burden and disparities. Conducted predictive modeling and survival analysis to measure treatment benefits while addressing unmeasured confounding factors.

Clinical Trial Data Reanalysis: Reanalyzed Phase II/III clinical trial data using machine learning techniques (e.g., random forests, SVM, neural networks) to predict patient benefits, adverse events, and identify key biomarkers. Developed models to optimize therapeutic strategies and improve clinical decision-making.

Health Disparities Research: Conducted decomposition analysis (e.g., Blinder-Oaxaca) to quantify the contributions of social and clinical factors to geographic disparities in mortality among older adults. Applied G-formula and causal inference to estimate direct and indirect effects. Data Integration and Method Development: Led projects to merge large-scale EHR, Medicare, and clinical trial datasets, developing statistical protocols for data quality assessment and bias correction. Collaborated with multidisciplinary teams to refine research methodologies and improve data-driven insights.

2022-2023

STATISTICIAN II, LINKDOC TECHNOLOGY

2

Real-World Studies (RWS): Designed and executed real-world studies for global pharmaceutical clients, focusing on methodological rigor, bias control, and real-world data analytics. Drafted SAPs to support regulatory submissions and clinical impact assessments. Digital Health Projects: Led the evaluation of AI-based malignant pulmonary nodule prediction systems in randomized, observational, and synthetic trial arms. Managed project design, sample size estimation, bias adjustment, and statistical analysis. Market Survey Analysis: Conducted reliability and validity testing for real-world studies on MSI/MMR testing and treatment patterns in colorectal cancer. Applied Bayesian stratified sampling to reduce bias, enhanced data extraction from EHR, and developed predictive models for patient journey analysis.

2020 - 2022

RESEARCH FELLOW & ASSISTANT, OSAKA UNIVERSITY

Field Epidemiology: Conducted community-based RCTs and observational studies in collaboration with local health departments. Analyzed data on morbidity, hospitalization, health insurance expenditure, survival outcomes, and quality of life. Study Design and Implementation: Developed epidemiological methodologies for longitudinal cohort studies, including data collection, bias analysis, and causal inference modeling. Managed projects focused on health economics and social medicine. EDUCATION

MAR. 2022

PHD IN MEDICINE (EPIDEMIOLOGY), OSAKA UNIVERSITY

MAY 2017

BACHELOR OF MEDICINE, SHANDONG UNIVERSITY

BACHELOR OF LAW, SHANDONG UNIVERSITY

SKILLS

• Statistical Programming: SAS (Proficient), R

(Proficient), Python, Stata, SQL, Power BI

• Analytical Methods: Regression analysis,

survival analysis, logistic regression, structural equation modeling, machine learning (random

forests, SVM)

• Real-World Evidence (RWE): Target trial

emulation, synthetic control, quantitative bias

analysis, propensity score matching

• Data Management: EHR, Medicare, SEER, NCDB,

5% Medicare (Parts A, B, D), clinical trial data

• Research Design: Cohort studies, cross-

sectional studies, RCT, mixed methods,

patient-centered outcomes

• Languages: English (Fluent), Japanese

(Fluent - N1), Chinese (Native)

3

PUBLICATIONS

Ouyang M, Eshak ES, Muraki I, et al. Association between Dietary Manganese Intake and Mortality from Cardiovascular Disease in Japanese Population. J Atheroscler Thromb. 2022. Wang Y*, Ouyang M*, et al. Phocea, Pseudoflavonifractor, and Lactobacillus intestinalis as Biomarkers of Obesity-Induced Type 2 Diabetes Mellitus. Diabetes Metab Syndr Obes. 2020. Zhang L, Yue Y, Ouyang M, et al. Effects of IGF-1 on TNF-α-Treated Neurons. Neurochem Res. 2017. Xiao X, Yu X, Ouyang M, et al. Arm Circumference and Mortality in Diabetes. Nutrients 15 (4), 961. 2023. Shang Q, Wang H, Ouyang M, et al. Exploration of Optimal Synergistic Treatment Strategies of Postoperative Radiotherapy and Immunotherapy in Early-Stage Breast Cancer. Cancer Research 85

(8_Supplement_2), LB216-LB216. 2025.

Yao S, Shang Q, Ouyang M, et al. Designing Single-Arm Clinical Trials: Principles, Applications, and Methodological Considerations. Annals of Clinical Epidemiology, 25011. 2025. Under submission:

The direct and indirect impact of exposure to ambient air pollutants and co-existing morbidity on the risk of, and disparities in, Alzheimer's disease and co-existing morbidity-related dementias (Accepted) Impact of Treatment Sequence of Immunotherapy and Stereotactic Radiotherapy on Survival in Non- Small Cell Lung Cancer Patients with Brain and Bone Metastases: An NCDB Data Analysis (Accepted) Evaluating Axillary Lymph Node Metastasis Risks in Breast Cancer Patients Using Semi-ALNP: A Multicenter Study (Accepted)

CERTIFICATIONS

SAS Certified Clinical Trials Programmer Using SAS 9 SAS Certified Specialist: Base Programming Using SAS 9.4 Clinical Research Online Professional Certification (Osaka University) REWARDS

First Prize, National Undergraduate Innovation Project (2015) Third Prize, Shandong University School-Level Challenge Cup (2014)

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