Linke L. Email & Phone Number

Shanghai, China

• Assimilated CDISC standards and FDA requirements for clinical and nonclinical trial data tabulations (SDTM, SEND), then developed an extensible, comprehensive custom rulebook for data quality check (QC) on toxicology data (SEND);• Developed, debugged, implemented SAS macros to identify multiple data tabulation errors, organized them into QC reports, delivered presentations and provided constructive feedbacks to the Toxicology Department during cross-department meetings;• Identified a critical programming logic flaw in an existing SDTM macro, communicated reasonings and evidence with senior managements, resulting in SAS macro reconstruction and enhanced data integrity for future data submission to the FDA;

Hangzhou, Zhejiang, China

• Effectively stabilized animals during clinical procedures, calculated medical dosages, ensuring pharmaceutical safeties;• Collected physiological data, wrote medical records, and handled various companion and exotic animals, conveying clinical knowledge and information to pet owners;

Master Of Science - Ms

Bachelor Of Applied Science - Basc