Lingyun Wang

Detail-oriented Biostatistician with 4 years of experience supporting Phase I-III clinical trials, with therapeutic expertise in Oncology, Hematology and Autoimmune Disorders, including Immune Thrombocytopenia (ITP). Proficient in SAS programming, CDISC standards (SDTM and ADaM), TLF development, and statistical analysis, with experience supporting biostatistical activities across the clinical development lifecycle. Experienced in FDA regulatory submissions, including Pinnacle 21 validation, Define-XML, CSDRG, and ARM, and delivering high-quality, submission-ready clinical trial outputs.

Adept at collaborating with cross-functional clinical, statistical programming, and data management teams to ensure accurate, compliant, and timely study deliverables.

Statistical Programmer Analyst Level II at SCiAN (2024-09 – Present)

• Delivered 5 interim database lock and 3 final database lock
• Contributed to drug approvals across international markets by supporting global regulatory inspections with health authorities, including the FDA, EMA, PMDA and NMPA
• Led the development of CSDRG, Define.xml and Analysis Results Metadata(ARM)
• Created reusable macro functions to streamline programming across multiple programs, improving efficiency and promoting standardized processes
• Programmed primary efficacy endpoint and safety analysis TLFs, applying statistical methodologies such as Wilson score intervals and Kaplan–Meier estimates to support clinical data reporting
• Participated in SAP review and revision cycles, incorporating feedback from cross-functional stakeholders and ensuring documentation was clear, accurate, and traceable to the protocol

Statistical Programmer Analyst Level I at SCiAN (2022-09 – 2024-09)

• Prepared SDTM/ADaM specification documents, implemented SDTM/ADaM mapping
• Annotated eCRF per SDTM mapping
• Performed SDTM/ADaM data validation on Pinnacle 21 and provided resolution to issues
• Produced data validation reports, protocol deviation identification reports, quality control checks, etc.

Honours Bachelor of Science in Double major in Mathematics and Statistics – University of Toronto (St.George campus) (2018-09 – 2022-09)