Clinical Trial Duke University

Kexin (Kate) Fang

919-***-**** *****@****.*** LinkedIn

EDUCATION

Duke University, School of Medicine, Durham, NC

Master of Biostatistics 2025-05

Relevant Courses: Statistical Theory & Methods, Causal Inference, Generalized Linear Model, Longitudinal & Correlated Data Nanjing Medical University, Nanjing, Jiangsu

Bachelor of Science, Pharmacy 2023-03

Relevant Courses: Linear Algebra, Biochemistry, Physiology, Pharmacology, Molecular Biology, Immunology, Microbiology, Clinical Pharmacology, Biopharmaceutics and Pharmacokinetics, Clinical Trials TECHNICAL SKILLS

• Software: R(dplyr, tidyverse, ggplot2, ggsurv, survminer), SAS (BASE, STAT, GRAPH), Python, SPSS, Stata, SQL

• Statistical Skills: Clinical Trial Data Analysis, Survival Analysis, Statistical Analysis Plan (SAP) Writing, Sample Size Calculation, Regression Modeling, Model Evaluation, Data Imputation, PCA, Data Visualization WORK EXPERIENCE

Duke University, Department of Science and Society, Durham, NC Consultant Intern, Ginkgo Bioworks 2024-05 to 2024-07

• Consulted with Ginkgo Bioworks to develop an FDA-compliant ethical framework, enhancing regulatory compliance and risk mitigation in pharmaceutical and biotech projects, which led to the approval of two new partnerships.

• Led a team of 4 to develop an extensive literature review, summarizing over 10+ international regulations (e.g., FDA, EMA) on controlled substances and providing detailed guidelines to enhance ethical decision-making efficiency

• Excelled in communicating complex concepts by managing weekly updates and orchestrating expert interviews over the 3 months, producing a 6-minute video that significantly enhanced stakeholder understanding Children’s Hospital of Nanjing, GCP Agency Office, Nanjing, Jiangsu Data Analyst Intern 2023-02 to 2023-06

• Queried and compiled Electronic Health Records (EHR) data of 200+ patients diagnosed with ADHD to investigate the efficacy, safety, and accessibility of the pharmaceutical atomoxetine

• Designed a 21-question questionnaire for parents of ADHD patients to assess the accessibility of atomoxetine in three ways: affordability, ability to obtain the drug, and medication compliance

• Developed SAS programs to clean and merge raw data into analysis-ready datasets using various techniques (one-to-one, one-to-many, left/right joins)

• Retrospectively analyzed efficacy and safety of atomoxetine in 30 ADHD patients over 12 weeks, comparing clinical indicators using t-tests and ANOVA, and independently authored a manuscript summarizing the study's objectives, methodology, findings, and implications

ACADEMIC RESEARCH

Duke University, School of Medicine, Durham, NC

Research Assistant 2024-06 to Present

Advisor: Prof. Sheng Luo

• Conducted extensive exploratory biomarker (PIK3CA mutation) analysis on Roche's phase III breast cancer clinical trial data via the Vivli platform. Proficient in R for survival and subgroup analyses (PFS, OS, ORR) to identify potential enrichment strategies

• Created insightful data visualizations (e.g. KM curves and forest plots) to illustrated survival difference across different gene mutations and independently authored a detailed analytical report

• Demonstrated a strong understanding of clinical trial documentation through review of 3 study protocols, Statistical Analysis Plans(SAPs), and with comprehensive understand the clinical trial datasets structure

• Contributed to the broader breast cancer research initiative by delivering key statistical insights through clinical trial and NCDB data analysis, applying advanced causal inference methods such as IPTW and PSM to support robust research Nanjing Medical University, Department of Clinical Pharmacology, Nanjing, Jiangsu Research Assistant 2021-10 to 2022-05

• Retrieved clinical data on the procurement of anti-cancer drugs from the Nanjing Regional Hospital Drug Analysis System database. Collected and created tables of 30+ anti-cancer drugs, selecting 3 drugs that aligned with the research goals

• Applied interrupted time series (ITS) design to analyze the impact of local health policies on drug accessibility and affordability (2013–2020) in Nanjing, China. Conducted regression analysis and visualized pre- and post-policy drug availability using R

• Co-authored published research (third author): “Trends in accessibility of negotiated targeted anti-cancer medicines in Nanjing, China: An interrupted time series analysis.” Front. Public Health 10:942638. doi: 10.3389/fpubh.2022.942638

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