Biostatistician

Biostatistician — TheraHealth Research

Boston, MA | January 2023 – Present

• Authored 6 comprehensive statistical analysis plans (SAPs) and sample size calculations for Phase II and III oncology trials, ensuring 100% compliance with CDISC standards and zero protocol deviations.
• Developed and validated 40+ CDISC-compliant SDTM and ADaM datasets using SAS macro programming, reducing data preparation latency by 24% and accelerating FDA submission timelines by 12 days.
• Collaborated with clinical operations to monitor safety databases for 3 active multi-center trials, identifying and resolving over 150 data queries to maintain a database error rate under 0.5%.
• Constructed survival analysis and Cox proportional hazards pipelines in R to analyze primary efficacy endpoints for a 1,200-patient trial, leading to the regulatory approval of an oncology candidate.

Associate Biostatistician — Veritas Clinical Analytics

Durham, NC | September 2020 – December 2022

• Assisted in the design and statistical programming of 4 Phase I and II immunology clinical trials, performing power analysis and sample size estimations that reduced trial design costs by 15%.
• Programmed 80+ SAS and R macros for automated table, listing, and figure (TLF) generation, boosting the statistical programming team's report generation efficiency by 28% over a 12-month period.
• Performed exploratory data analysis and logistic regression modeling on historical registry data of 5,000+ patients, identifying 3 key covariates that improved clinical endpoint prediction by 16%.
• Reviewed case report forms (CRFs) and data management plans for 5 studies, correcting 90+ data discrepancies and ensuring study alignment with statistical analysis requirements prior to database lock.

Statistical analysis plans (SAPs), Sample size estimation, Power analysis, Survival analysis, CDISC standards, SDTM, ADaM, SAS, R, Python, SPSS, SQL, Clinical trials, Regulatory submissions

Phase III Oncology Trial Analysis

Role: Lead Biostatistician

Tools: SAS, R, CDISC SDTM/ADaM, Git

Led the statistical analysis for a 400-patient multicenter oncology trial, delivering the final clinical study report 10 days ahead of schedule with zero errors.

Cardiovascular Registry Modeling

Role: Biostatistician

Tools: R, Python, SQL, LaTeX

Analyzed observational data from a registry of 15,000 patients, constructing Cox regression models that identified 4 key cardiovascular risk factors with 95% confidence.

• SAS Certified Clinical Trials Programmer Using SAS 9 (2021)
• ASA Graduate Statistician (GStat) (2020)

• Languages: English (Native), Mandarin (Conversational)
• Volunteer Work: Statistical consultant for local public health community surveys (2021-present)
• Availability: 2 weeks notice