Open to opportunities

Zhiwei Li

@zhiweili

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Biostatistician and statistical programmer specializing in clinical trials.

China

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What I'm looking for

I seek roles where I lead biostatistics programming and study design for phase 2/3 trials, collaborate cross-functionally, and drive regulatory-quality deliverables.

I am a biostatistician and statistical programmer with hands-on experience across phase 1–3 clinical trials and IITs, supporting therapeutic areas including pain, neurological, respiratory, autoimmune, and urinary diseases.

I develop study protocols, determine sample size and go/no-go strategies, write and review SAPs and TFL shells, and validate SDTM/ADaM datasets to ensure regulatory compliance with ICH and GCP.

I have led and contributed to pivotal studies—designing randomized withdrawal trials, generating complex efficacy datasets (including e-diary–derived endpoints), and acting as internal lead for DMC meetings—while building RBM frameworks and biostatistics SOPs.

I am proficient in SAS and R, perform advanced simulations and missing-data methods, and have published methodological and applied research; I seek to apply this expertise to high-impact clinical development programs.

Experience

Work history, roles, and key accomplishments

Current

Biostatistician

Current

SIMR Biotechnology

Dec 2024 - Present (1 year 2 months)

Developed phase 1–2 protocols and sample size/go–no–go strategies across multiple TA (pain, respiratory, urinary), designed a randomized withdrawal pivotal study for trigeminal neuralgia, and established ICE strategies and RBM framework to support data verification and site management.

SAP TFL Review Risk Based Monitoring R SAS

Statistical Programmer

Everest Clinical Research

Mar 2023 - Dec 2024 (1 year 9 months)

Developed ADaM/efficacy datasets and TFLs for 20+ phase 2/3 projects (including AbbVie/Allergan-sponsored pivotal studies) and led DMC support and post-lock safety analyses for phase 3 trials such as schizophrenia.

SAS R Clinical Programming CSR SAR Generation

Assistant Biostatistician

GCP-ClinPlus

Jul 2022 - Mar 2023 (8 months)

Authored and updated SAPs and TFL shells across 20+ projects, led phase 1 and phase 3 studies (psoriasis, PHN) with FDA/NMPA submissions, performed 3rd-level QC on TFLs, and implemented simulation and advanced missing-data methods in R/SAS.

SAP Development TFL Shells R SAS Simulation Regulatory Submissions

Education

Degrees, certifications, and relevant coursework

Sun Yat-sen University

Master of Science, Epidemiology and Medical Statistics

2019 - 2022

Activities and societies: Teaching assistant, statistical consultant, intern at International Health Research Center of Guangdong Provincial People's Hospital; poster accepted at 2021 China Biostatistics Academic Annual Conference (2nd prize).

Master's degree in Epidemiology and Medical Statistics focusing on public health methods and biostatistical analysis.