Shuchun Wu
Pudong New District, Shanghai,China
Summary
Experienced Statistical Programmer with over 2.5 years of experience in CRO. Excellent reputation for proficiency in programming in SAS, ample knowledge of CDISC/GCP as well as solid understanding of the development and use of standard macros. Ability to produce timely and high quality deliverables under guidance, specially in global Oncology projects
Overview
3
3
Certifications
4
4
years of post-secondary education
3
3
years of professional experience
Work History
R&D Analyst II
Clinical Research Co., Ltd
Shanghai, China
09.2020 - Current
- Focused on develop and testing standard SDTM, ADaM or TFL macros for project teams
- Generated standard specs, reviewed and updated if necessary.
- Develop new tools for project teams as demand
Statistical Analyst II
Clinical Research Co., Ltd
Shanghai, China
01.2020 - 08.2020
- Led a Phase I oncology project, drafted SDTM specifications, participated in major programming, reviewed the output and delivered output in high quality.
- Participated in many oncology studies in good quality and learned advanced SAS skills of statistical models.
- Completed and maintained all the common SDTM domains, especially for LB, PC, EG, IS, etc.
- Completed and maintained all the common ADaM domains, especially for ADEVENT, ADTTE, ADEXSUM, ADTR, ADLB, etc.
- Drafted ADDV specification according to the protocol and compared them with PD records from clinical function.
- Created CRF annotation, checked P21 issues and generated the define package.
- Took part in an IDB project, combined individual studies and ensured consistency.
- Be a programming leader for a Phase I ML study and create SDTM, ADaM, TFL.
Statistical Analyst I
MacroStat (China) Clinical Research Co., Ltd
Shanghai, China
03.2018 - 12.2019
- Received the orientation training and basic SAS skills and statistical knowledge training.
- Learned the regulations of the medical industry.
- Obtained the training about the principles of company’s SOPs and clients’ SOPs.
- Obtained the training about GCP and the GCP certificate.
- Drafted TFLs requirement according to Mockup and completed all programming in dummy project.
- Received and completed business speaking and writing English training.
- Configured SDTM per study document, like CRF, protocol and SAP.
- Maintained programs created by others for several studies.
- Received the orientation training and basic SAS skills, statistical knowledge and
- Obtained the training about company’s SOPs, clients’ SOPs and GCP rules.
Education
Bachelor of Science - Statistics
School Of Mathematics And Science, Nanjing Normal University
Nanjing, Jiangsu Province, China 09.2013 - 07.2017
Skills
Englishundefined
Certification
Passed SAS Certified Base and Advanced Programmer Exams
Timeline
R&D Analyst II
Clinical Research Co., Ltd
09.2020 - Current
Statistical Analyst II
Clinical Research Co., Ltd
01.2020 - 08.2020
Statistical Analyst I
MacroStat (China) Clinical Research Co., Ltd
03.2018 - 12.2019
Bachelor of Science - Statistics
School Of Mathematics And Science, Nanjing Normal University
09.2013 - 07.2017
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