1. Ensure timely deliverable of a DM SAS Programming group with high quality and compliance with industry guidelines, regulatory requirement, SOPs in clinical trials.
2. Streamline working process and improve efficiency.
3. Review or develop DM documents include but not limited eCRF, Edit Check Specification, Data Transfer Agreement, SDTM documents and so on following SOPs
4. Develop SAS program for non-EDC edit checks, listings for data review, external data integration and reconciliation etc.
5. Create aCRF, Mapping Specification, metadata, SDRG etc. for SDTM package. Develop SAS program for SDTM package and QC of SDTM package
6. Design SAS macro system and develop SAS macro
7. Design, build and maintain metadata repository
8. Create and/or review related documents
Requirements:
1. Extensive experience in DM SAS programming
2. Education: Bachelor or Master Degree in Biostatistics, Statistics, Epidemiology, Mathematics, or Computer Science other scientific field (or equivalent theoretical/technical depth).
3. Good communication skill, project management and/or people management skill
4. Advanced clinical trial knowledge and good understanding on DM processes
5. Extensive knowledge of CDISC standards include but not limited to CDASH, SDTM, Define etc.
6. Excellent in Oral and writing English
职能类别: 临床协调员 临床数据分析员
联系方式
上班地址:上海市虹口区花园路66弄嘉和国际大厦1号楼16楼
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