Qianhui Zhao
Redmond,WA
Summary
Master’s degree Statistical SAS Programmer with 8 years of experience in clinical trials across oncology, diabetes, and cardiology. Expertise in SAS Base, Macro, Stat, and Graph, with a strong focus on CDISC SDTM/ADaM standards and data integrity for submission-ready packages. Proven track record in continuous process improvement, integrated summaries generation, and CRO oversight, utilizing Pinnacle 21 for risk-based validation and quality control.
Overview
8
8
years of professional experience
Work History
Statistical Programmer
BeiGene
02.2023 - 05.2025
- Developed SAS programming for outsourced oncology trials and internal ISS/ISE analyses.
- Reviewed CRO deliverables to ensure on-time delivery and high data quality through risk-based validations.
- Created and validated ADaM datasets and TFLs for Phase 2/3 integrated summaries.
- Collaborated with cross-functional teams to resolve pre- and post-database issues.
- Generated patient profiles and data review listings to support clinical data review.
- Reviewed SAP, mock shells and DTS to ensure regulatory compliance and consistency.
- Supported programming activities for annual reporting such as DSUR and PBRER.
Statistical Analyst
Pharmaron
07.2020 - 12.2022
- Performed multiple projects in different therapeutic areas (oncology, cardiology, diabetes).
- Developed and validated detailed specifications and datasets for SDTM/ADaM.
- Created and reviewed annotated CRFs, ensuring mapping accuracy and data completeness.
- Wrote and maintained SAS programs to produce TFLs per SAP mock shells.
- Conducted parallel programming validation for SDTM, ADaM, and TFLs.
- Led programming activities for clinical studies, assigning tasks and tracking progress.
- Developed and customized SAS macros to improve programming efficiency and accuracy.
- Prepared SDTM/ADaM packages for regulatory submissions.
- Validated data packages using Pinnacle 21, identifying and resolving compliance issues.
Statistical Programmer
TigerMed
07.2017 - 05.2020
- Performed safety and efficacy analyses for phase 2/3 oncology and diabetes trials.
- Drafted and refined ADaM/SDTM specifications, clarifying derivations and metadata.
- Transformed raw data into SDTM domains and ADaM datasets per mapping specifications.
- Generated TFL outputs for safety and efficacy analysis as per SAP and mock shells.
- Prepared annotated CRFs to support submission package.
- Performed ad-hoc/post-hoc requests or data listings using existing macros.
- Performed edit checks and reported data issues to clients to ensure quality control.
Education
Master of Science - Statistics
Northeastern University
SAS Base
Skills
- SAS Base/Macro/Stat/Graph programming
- Clinical data analysis
- SAS Base/Macro/Stat/Graph
- CDISC SDTM & ADaM
- TFL generation
- Data quality review
- definexml
- annotated CRFs
- ISS/ISE integrated summaries, DSUR, and PBRER safety reporting
- Pinnacle 21 Validator
Timeline
Statistical Programmer
BeiGene
02.2023 - 05.2025
Statistical Analyst
Pharmaron
07.2020 - 12.2022
Statistical Programmer
TigerMed
07.2017 - 05.2020
Master of Science - Statistics
Northeastern University
SAS Base
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