
工作职责:
Principle Responsibilities:
1. Ensure timely deliverable of a DM SAS Programming group with high quality and compliance with industry guidelines, regulatory requirement, company processes.
2. Streamline working process and improve efficiency.
3. Develop SAS program for non-EDC edit checks, listings for data review, external data integration and reconciliation etc.
4. Create aCRF, Mapping Specification, metadata for SDTM package. Develop SAS program for SDTM package and QC of SDTM package
5. SAS macro as well as SAS macro system development
6. Design, build and maintain metadata repository
7. Create and/or review related documents
任职资格:
Education and Experience Requirements/Qualifications:
• Education: Bachelor or Master degree in statistics, medical statistics, clinical epidemiology, computer science, mathematics or other scientific field (or equivalent theoretical/technical depth).
• 8 years experience programming with B.S. degree, 6 years with Master degree, preferably in a global pharmaceutical/CRO company.
• Good communication skill, project management and/or people management skill
• Advanced clinical trial knowledge and good understanding on DM processes
• SAS programming practices with extensive knowledge of SAS programming language
• Extensive CDISC Knowledge include but not limited to CDASH, SDTM, Define etc.
• Good understanding on Industry guidelines, CFDA/FDA/EMEA regulatory requirement
• Good in Oral and writing English