Responsibilities:
1.Study Programmer:
-Develop programs to produce SDTM/ADaM datasets, tables, listings, and graphs according to specifications
-Develop specifications
-Performs ad-hoc analysis as requested
2.Perform quality control, as required per SOPs, for statistical programming deliverables
3.Provide items required for submission (i.e. SAS transport files, define.pdf/xml, annotated CRF).
4.Implement and contribute to statistical analysis plans; provides additional expertise in the analysis of clinical trial as it relates to protocol development, case report form design and data collection/review
5.Oversee the programming tasks of CRO vendors

Qualifications & Certificates:
1.B.S. or M.S. degree in quantitative science disciplines, Statistics, pharmacy or related disciplines
2.Base SAS, SAS/STAT, SAS Graph and SAS Macro, Strong SAS programming skills, and other statistical and data processing software e.g. R/ Python.
3.Good oral and written communication skills in Chinese and English
4.At least 2-year experience in clinical data analysis
5.Ability to independently manage multiple tasks and projects
6.Familiar with CDISC standards(SDTM IG, ADaM IG, Define requirement)
7.Knowledge of clinical drug development process, and applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

其他信息

行业要求：全部行业