PINGPING CHEN
Cincinnati,OH
Summary
Statistical Analyst with 3 years of experience in clinical trail programming (Phase I–III). Expert in SAS programming and CDISC standards (SDTM/ADaM). Proven track record in delivering high-quality TFLs and ensuring data integrity through rigorous QC validation across therapeutic areas including Oncology, NASH, HAE, etc. Adept at bridging the gap between biostatisticians and data management to meet critical regulatory deadlines.
Overview
4
4
years of professional experience
Work History
Statistical Analyst
Medpace
01.2022 - Current
- Lead Statistical Programming: Drive the development of ADaM datasets and TFLs for Phase I-III trails, ensuring 100% compliance with CDISC standards and regulatory requirements.
- Randomization Services: Developed and executed SAS programs to generate randomization schedules, ensuring precise implementation of block randomization and stratification factors as defined by the SAP.
- Oncology Expertise: Spearhead data analysis for complex Oncology programs, expertly programming and validating key efficacy endpoints such as PFS, ORR, CBR, and DOR.
- Study support: Execute data analysis for Randomized Controlled Trials (RCT) and Phase I/II Dose-Escalation studies, managing intricate data derivations and DLT reporting.
- Technical Documentation: Author and refine ADaM Specifications and TFLs shells, ensuring seamless alignment between Statistical Analysis Plan (SAP) and final deliverables.
- QC & Data Integrity: Oversee rigorous QC validation to identify and resolve mapping inconsistencies, ensuring the accuracy and traceability of submission-ready outputs.
- Cross-functional Collaborations: Partner with Biostatisticians to implement statistical methodologies and resolve complex data issues during the trail lifecycle.
Education
Master of Science - Applied Statistics
Wright State University
Dayton, OH04-2022
Bachelor of Science - Accounting
Wright State University
04-2020
Skills
- SDTM & ADaM: Expert in SDTM-to-ADaM mapping, developing ADaM specifications, and ensuring end-to-end traceability
- Compliance: Proficient in OpenCDISC/Pinnacle 21 validation and resolving data mapping issues to meet regulatory standards
- Core SAS: Advanced SAS base, SAS Macro, and SAS SQL programming for large-scale clinical datasets
- Randomization: Specialized in developing SAS programs to generate randomization schedules, incorporating block randomization and stratification factors
- Deliverables: Specialized in TFL Programming (Tables, Listings, and Figures) for Phase I-III clinical study reports (CSR)
- Validation: Extensive experience in QC validation (double programming), SAP interpretation, and peer review of analysis datasets
- Therapeutic Areas: Deep expertise in Oncology, NASH, HAE, CRS, and Hepatic Infusion Therapy
- Process Flow: Adept at data cleaning, endpoint interpretation, and collaborating with Biostatisticians, Data management, and Medical Writing
- Other Tools: R/RStudio (Statistical Modeling)
Languages
English
Full Professional
Chinese (Mandarin)
Native or Bilingual
Timeline
Statistical Analyst
Medpace
01.2022 - Current
Bachelor of Science - Accounting
Wright State University
Master of Science - Applied Statistics
Wright State University