Chunsong Qu
Associate Director Statistical Programming at Moderna Inc Oncology | Hematology | Immunology | Virology | CDISC | SAS | R
- Role
- Associate Director, Statistical Programming - Immunology of Infectious Disease at Moderna
- Location
- Summit, NJ, US
- LinkedIn followers
- 500 followers
About Chunsong Qu
17+ years’ experience of statistical analysis and programming in biopharmaceutical/biotech industry.• Familiarity with ICH guidelines, FDA/EMA regulation requirements, clinical milestone documents.• Proven experience in efficiently leading and managing internal staffs and overseeing vendors’ programming activities.• Expertise in oncology/hematology clinical studies, including response criteria, endpoints, and analysis methods for both safety and efficacy.• Extensive experience in CDISC standards for both SDTM and ADaM.• Comprehensive knowledge of statistical methodology used in clinical studies.• Thorough capability of creating/validating CSR/ISS/ISE and preparing FDA/EMA submission packages. • Strong analytical and problem-solving skills; excellent organization and time management skills; ability to work both independently and collaboratively in cross-functional study teams.
Experience
Associate Director, Statistical Programming - Immunology of Infectious Disease
Jun 2022 — Present · NJ, US
Education
University of Waterloo
Master of Mathematics, Biostatistics
2006 — 2008
Skills
- Sas
- Sdtm
- Clinical Development
- Clinical Trials
- Statistical Programming
- Clinical Data Management
- Oracle Clinical
- Edc
- Biostatistics
- Therapeutic Areas
- 21 Cfr Part 11
- Ctms
- Ich-Gcp
- Sas Programming
- Survival Analysis
- CRO
- Drug Development
- Clinical Study Design
- Pharmacovigilance
- Crf Design
- Clinical Research
- Data Management
- Regulatory Submissions
- Pharmaceutical Industry
- Cdisc
- Oncology
- Protocol
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