Lei Wang

Senior Biostatistician with 14+ years of post-graduate experience in biostatistics, clinical trials, and real-world evidence (RWE) research across academic, research, and pharmaceutical settings, including 12+ years of experience supporting the design, analysis, and reporting of Phase I–IV clinical trials. Proven track record of collaborating with physicians, epidemiologists, data management and statistical programming teams, and cross-functional research partners to deliver high-quality statistical solutions that support clinical and scientific decision-making. Proficient in SAS and R, with extensive experience in statistical modeling, simulation studies, longitudinal data analysis, survival analysis, interim analyses, missing data methodologies, multiplicity adjustment strategies, sensitivity analyses, real-world data analytics and latent pattern analysis.

Expertise in dimensionality reduction techniques for zero-inflated, high-dimensional data, demonstrated through first author in a peer-reviewed methodological publication. Possess working knowledge and practical experience in Bayesian methods, adaptive clinical trial designs, and group sequential methodologies. Strong communicator with expertise in methodology selection, data interpretation, quality assurance, and translating complex scientific questions into robust quantitative solutions.

Senior Biostatistician at St. Jude Children's Research Hospital (2023-11 – Present)

Department of Epidemiology and cancer control

• Leverage Real-World Evidence (RWE) and longitudinal follow-up data to evaluate long-term health and survivorship outcomes in pediatric cancer survivors.
• Manage and analyze epidemiologic and patient-reported outcome (PRO) data across clinical and observational studies, including mental health (Brief Symptom Inventory, BSI), health-related quality of life (SF-36), disease-specific instruments (NCQ), and standardized PRO measures (PROMIS), to support clinical endpoints, statistical analysis, and evidence generation.
• Design and perform longitudinal and cross-sectional analyses of patient-reported outcomes, including psychological well-being, physical functioning, fatigue, pain interference, sleep, and overall health-related quality of life, to evaluate disease burden, treatment-related changes and social economic impact over time.
• Collaborate with team members to prepare reports and disseminate study findings through peer-reviewed manuscripts, abstracts, and oral presentations.
• Working with faculty biostatisticians, implement frontline statistical methods in exploratory research studies.

Senior Biostatistician II at ICON Clinical Research (2022-03 – 2023-05)

Department of Biostatistics

• Served as Biostatistics & Programming (B&P) Lead and Lead Statistician for multiple Phase I and Phase III clinical trials in COVID-19 vaccine and CAR-T Lymphoma area, independently overseeing all statistical deliverables (DSMB reports, interim analyses, IB updates, final analyses, and eSubmissions).
• Accountable for planning, coordinating, and overseeing activities of biostatisticians and programmers across assigned studies and programs, ensured timely, on-budget delivery while maintaining consistency and regulatory compliance.
• Reviewed clinical study protocols as statistical lead, ensuring appropriate study design and robust statistical methodology; contributed to development of statistical sections within protocols.
• Developed Statistical Analysis Plans (SAPs), including appropriate statistical methodologies and procedures; designed randomization plans, oversaw generation of randomization codes, and validated randomization lists.
• Coordinated cross-functional project teams within biostatistics, led team meetings, managed project timelines, assessed resource needs, and monitored study progress.
• Collaborated closely with sponsors across all project phases and represented statistical function in communications with regulatory agencies as needed.
• Reviewed SDTM data specifications and partnered with Data Management to refine eCRF design to meet study requirements; developed ADaM specifications and oversaw development and validation of analysis datasets in collaboration with programming and data management teams.
• Developed tables, listings and figures TLF shells and corresponding statistical specifications; Excellent programming skills for quality control on critical outputs, efficacy/safety tables and working closely with Programmers to ensured high-quality deliverables.
• Contributed to clinical study reports (CSR), data monitoring committee (DMC) reports, development safety update reports (DSUR), and manuscripts; drafted statistical methods sections.
• Provided review and oversight of eSubmission packages to ensure statistical accuracy and regulatory compliance.

Senior Biostatistician at St. Jude Children's Research Hospital (2021-12 – 2022-03)

Department of Biostatistics

Biostatistician at St. Jude Children's Research Hospital (2018-11 – 2021-12)

Department of Biostatistics

Statistical Analyst at St. Jude Children's Research Hospital (2016-01 – 2018-11)

Department of Biostatistics. Focused on Phase I-III Leukemia clinical trials.

• Collaborated with faculty statisticians, physicians, and multidisciplinary teams to provide statistical support for study design, sample size determination, protocol development, interim analysis planning, and Statistical Analysis Plan (SAP) development.
• Reviewed case report forms (CRFs) and provided statistical guidance on data collection strategies, database design, analysis dataset specifications, and data quality processes. Developed R functions and SAS macros to streamline data management and statistical analyses.
• Performed interim and final analyses, ensuring the application of appropriate methodologies and the generation of accurate, reproducible, and scientifically rigorous results.
• Led the preparation of Data Safety Monitoring Board (DSMB) reports and ClinicalTrials.gov submissions, with primary responsibility for generating and reviewing tables, listings, and figures (TLFs), interpreting study findings, and contributing to clinical study reports.
• Authored statistical sections of SAPs, clinical study reports, abstracts, peer-reviewed manuscripts, and scientific presentations.
• Provided statistical review and consultation for institutional clinical trial protocols and research studies, supporting study design, endpoint selection, and analytical strategy development.
• Provided statistical consultation for translational research studies by collaborating with physicians, biologists, and research scientists to define study objectives, develop analytical strategies, conduct exploration and inferential analyses, and interpret study findings.

Biostatistician at University of Tennessee Health Science Center (2014-01 – 2016-01)

Dept. of Preventive Medicine

• Provided statistical consultation and analytical support to the department of Surgery, department of Obstetrics and Gynecology and division of Emergency Medicine.
• Communicated with the physicians, performed programming, analysis of data, graphical presentation and reporting of results, interpretation and explanation of statistical techniques used, and making of valid inferences.
• Participated in manuscript and grant developments.
• Provided statistical consulting service to UTHSC physicians and researchers

Instructor at University of Memphis (2011-08 – 2014-01)

Department of Mathematical Sciences

• Taught statistics and probability courses
• Provided the statistical consulting service to other departments in the University of Memphis

Ph.D. in Statistics – Texas A&M University (2026)

M.S. in Statistics – Texas A&M University (2008)