工作职责：

Principle Responsibilities:
1. Be responsible for study level DM SAS programming and testing.
2. Review or develop DM documents include but not limited eCRF, Data Validation Plan, Data Transfer Agreement, SDTM documents and so on following SOPs
3. Develop SAS program for non-EDC edit checks, listings for data review, external data integration and reconciliation etc.
4. Create SDTM aCRF, Mapping Specification, metadata, SDRG etc. for SDTM package. Develop SAS program for SDTM package and QC of SDTM package
5. SAS macro development
6. 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).
• 5 years experience programming with B.S. degree, 3 years with Master degree, preferably in a global pharmaceutical/CRO company.
• Good communication and project 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