Clinical Data Manager & Biostatistician (臨床資料經理暨統計分析師)

[Responsibilities] Data Management: • Design and implement electronic data capture (EDC) systems • Develop and review Case Report Forms (CRFs) and data validation plans • Generate data management documentation: Data Management Plan (DMP), Data Validation Plan (DVP), and data listings • Perform database lock and archive activities in compliance with regulatory requirements • Coordinate with clinical operations, monitors, and sites to resolve data discrepancies • Oversee data collection, cleaning, and query resolution processes to ensure adherence to CDISC standards and ICH‐GCP guidelines Statistical Analysis: • Contribute to study design and protocol development, including sample size calculations and statistical analysis plans (SAPs) • Perform interim and final statistical analyses using SAS, R, or equivalent software • Generate tables, listings, and figures (TLFs) for clinical study reports • Support submission-ready deliverables for TFDA, FDA, EMA, and other health authorities • Interpret results, prepare statistical sections of protocols and reports, and present findings to cross-functional teams • Provide guidance on appropriate statistical methods and quality control of outputs [Requirements] • Master's degree or higher in Biostatistics, Statistics, Epidemiology, Data Science, or a related field • 3+ years of combined experience in clinical data management and biostatistics within the pharmaceutical or medical device industry • Proficiency in EDC systems (e.g., Medidata Rave, Oracle InForm) • Advanced programming skills in SAS and/or R • Hands-on experience with CDISC SDTM and ADaM standards • Strong understanding of ICH-GCP, FDA, TFDA, and EMA guidelines • Excellent written and verbal communication skills in English and Mandarin • Detail-oriented, with strong problem-solving and project management abilities