CV

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Qualification Highlights

• Solid training in theoretical and applied statistics with concentration in Biostatistics
• Hands-on experience in study designs, protocol reviewing and input, ADaM data conversion, SAP creation and review, data analysis, execution results interpretation, protocol reviewing and report writing.
• Familiar with evaluation and programming with SAS and R, proficient in statistical computing: 5+ years of experience in SAS and R, ability to work with SQL, Python and Git
• Experienced data visualization using SAS, R, R Shiny, Advanced MS Excel, visualization tool Highcharts and Apache ECharts
• Accustomed to critical thinking, communicating, and collaborating effectively with people of diverse organizational backgrounds.
• Detail oriented, think outside the box, and be able to problem solve, and trouble-shoot.
• Constantly learning every week, every month, every year for broad knowledge, continuing to broaden knowledge boundaries and stepping out of comfort zone

Experience

ICON plc (CRO Experience)

Senior Biostatistician; Mar.2023—present

• Statistical oversight of the entire clinical study
• Development of statistical analysis plans and report specifications for clinical trials
• Contribute to and review clinical study protocols and clinical study reports
• Responsible for the quality and delivery of the Table, Figure, and Listing packages (TFL)
• Analysis and interpretation of the results of clinical studies
• Development of statistical analysis plans and report specifications for simple to complex clinical studies
• Conducting statistical analysis and interpreting the results of simple to complex clinical studies
• Contributions to Protocol Risk Evaluation and Planning (PREP)
• Performing validation of TFLs, table datasets, and derived datasets
• Verification of simple to complex randomization specifications and dummy randomization schemes
• Training and instruction of new or younger statisticians in statistical methods and business processes

German Breast Group (Academic Experience)

Biostatistician; Oct.2022—Feb.2023

• Planning, monitoring, and evaluation of clinical trials in the field of breast cancer
• Advice on experimental design, research approaches, statistical requirements, and scientific standards
• Development of study proposals (including expertise on case numbers and randomization) and discussion with cooperation partners
• Management of statistical tasks related to clinical trials, including creation of statistical section of study protocols, SAP, mock TLFs, sample size
• Preparation and presentation of study data for IDMC
• Creation of the statistical analysis plan (SAP) and its implementation
• Programming, evaluation and processing of statistical results and creation of reports
• Analysis of biomarker projects
• Development and Verification of SAS Macros

GCP-Service International (CRO Experience)

Biostatistician; Mar.2020—Sep.2022

• More than 20 of executed international projects (Oncology, Ophthalmology, Respiratory Disease, Chronic Pain, Allergology, Chronic inflammatory, Wound care, Aesthetic Medicine, COVID-19 etc.)
• Lead multiple complex projects as lead biostatistician by building study design, consulting, and programming to implement analytic plans
• Communicate directly with sponsors and participate in budget discussions
• Host Data Review Meeting and drive other meetings to provide effective findings and recommendations to multiple levels of researchers
• Assist submission and obtaining approval for the study protocol from the EC, prepare feedback to discrepancy letter from EC
• Create randomization plans and generate randomization lists for multiple studies using SAS (block randomization, stratified variable block randomization)
• Conduct sample size calculation and prepare statistical analysis plans for more than 10 studies
• Carry out data clean and manipulation. Conduct data analysis of clinical, laboratory, survey measured data applying standard and non-standard statistical methodology from exploratory analysis to final model building, sensitivity analysis, diagnosis, necessary post-hoc subgroup analysis etc.
• Good knowledge of SAS (SAS BASE/SAS STAT/SAS GRAPH), efficient SAS macro programming to create standard RTF Output for TFLs
• Analyze data using statistical models in SAS and R, such as logistic regression, mixed model, classification, random forest, survival analysis, meta-analysis, cross-validation and bootstrapping, regularization, propensity score matching, Bayesian analysis
• Explore data as a data-loving member and identify key elements, perform model selection and diagnosis, and various visualization tasks
• Prepare Centralized Statistical Monitoring (CSM) Plan and implement
• Prepare Quality Risk Management Plan, conduct clinical trial within Clinical Quality Management System (CQMS) conceptual framework
• Experience in converting SDTM to ADaM data under the CDISC standard, and using ADaM data for programming to generate TFLs
• Provide support for academic conferences and publications
• Assist medical writing in the statistical part

Education

2018-2020

M.Sc. Medical Biometry/Biostatistics; University of Bremen (Germany)

2013-2017

B.Sc. Biological Engineering (Major); Tianjin University (China)

2013-2017

LL. B. Law (Minor)); Tianjin University (China)

Skill

Skill	Description
Language	Chinese – native
	English– advanced
	German – advanced
Computer	MS office, Several EDC systems (QCTMS EDC/Castor/ Viedoc)
	SAS BASE/SAS STAT/SAS GRAPH/SAS MACRO
	R, LaTeX, Markdown, Python, SQL and MySQL, Machine learning
Qualification	Senior Nutritionist Qualification
	IBM Data Analyst Professional Certificate (Python and SQL)
	IBM Data Science Professional Certificate (Python and SQL)
	IBM Data Analytics with Excel and R Professional Certificate (R and Excel)
	University of Harvard, Data Science-Machine Learning Certificate (R)
	University of California, SQL for Data Science Certificate (SQL)
	University of California San Diego, Drug Development Product Management Specialization
	Google Data Analytics Professional Certificate
	CFI-Statistics Fundamentals, Data Science Fundamentals
	MSI-Project Management Essentials Certified (PMEC)