About Me

Biostatistician with over 6 years of experience in mid-to-late-phase clinical trials. Demonstrated history of supporting projects across diverse therapeutic areas, including Autoimmune, Metabolic, Rare Diseases, Oncology, and Neuroscience. Experienced in regulatory submissions, contributing to successful NDA packages for the US FDA and China NMPA. Proficient in SAS and R, with a focus on applying sound statistical methodologies and collaborating effectively within global, cross-functional teams.

Education

MSc in Statistics (With Distinction) | 2018 – 2019

  • Academic Honors: Awarded a university scholarship for outstanding academic performance.
  • Performance: Ranked among the top of the cohort.

BS in Economic Statistics | 2013 – 2017

  • Concentration: Quantitative Economics and Mathematical Statistics.
  • Highlight: Specialized in high-level quantitative analysis, maintaining a strong academic record across core major requirements and advanced statistical modules.

Professional Experience

Biostatistician (Sponsor) | 2025 – Present

Specialized in Autoimmune Therapeutic Area.

  • Autoimmune Diseases (Pivotal Phase I, II, & III): Serve as Lead Statistician for compound-level programs. Responsible for study design, sample size determination, protocol design, and authoring Statistical Analysis Plans (SAPs). Oversee blinded efficacy monitoring to ensure study integrity and data quality.

Biostatistician (Sponsor) | 2025

Specialized in Metabolic, and Oncology Therapeutic Areas.

  • Metabolic Disease (Pivotal Phase III): Act as Lead Statistician overseeing Protocol development, including complex study design and sample size estimation, and SAP finalization.

  • Oncology (Phase III): Acted as Support Statistician addressing critical regulatory ad-hoc requests. Applied innovative statistical methodologies to resolve complex agency queries.

Biostatistician (CRO) | 2023 – 2025

Key focus on regulatory submissions and complex statistical analyses.

  • Rare Disease (Pivotal Phase III): Provided comprehensive NDA support for US FDA/EMA submission. Authored and executed SAP, Topline reports, Clinical Study Reports (CSR), and Statistical Methodology Appendices. Managed ISS/ISE SAPs, BIMO packages, and complex Ad-hoc analyses.
  • Respiratory (Pivotal Phase III): Supported US FDA/EMA/PMDA/China CDE NDA submission through the development of ISE SAPs and complex Pooling Analysis for CSRs.
  • Inflammation & Immunology (Pivotal Phase II & III): Developed SAPs and delivered Topline results and CSRs for pivotal studies.
  • Oncology (Phase III): Provided statistical support for US FDA NDA submission activities.

Biostatistician (Sponsor) | 2021 – 2023

Led programs resulting in NMPA approval and Breakthrough Therapy Designations.

  • Cardiovascular Disease (Pivotal Phase I & III): Served as Lead Statistician for a successful NDA submission to China’s NMPA (Approved). Managed full-cycle documentation including SAP, Topline, CSR, DSUR, and peer-reviewed publications.
  • Oncology (Phase I & IIb): Lead Statistician for a program granted Breakthrough Therapy Designation. Authored/reviewed Protocols, sample size calculations, SAPs, Interim CSRs, and DSURs.
  • Ophthalmology & Inflammatory Diseases (Pivotal Phase I & III): Acted as Lead Statistician for multiple compound-level studies, focusing on Protocol design, sample size estimation, and SAP/CSR review.

SAS/JMP Data Analyst (Healthcare Division) | 2021 – 2021

Technical development and client-facing statistical consulting.

  • JMP Development: Engineered custom JMP plug-ins using JSL (JMP Scripting Language) and SAS to automate clinical monitoring processes based on client requirements.
  • Client Training: Conducted statistical training sessions for diverse audiences, translating complex statistical concepts for non-technical stakeholders.
  • Account Management: Managed customer retention and satisfaction through technical support and strategic growth initiatives.

Statistical Programmer (Sponsor) | 2019 – 2021

Focus on Phase III execution and FDA approval milestones.

  • Inflammation & Immunology (Pivotal Phase III): Supported successful US FDA NDA submission and subsequent approval. Responsible for the programming of Topline results and CSRs.
  • Oncology (Phase I): Developed and validated SAS programs for early-phase clinical trial data analysis and reporting.

* Data cut: Sep 2026