Main Responsibilities
- Review and provide comments on study documents, including but not limited to, protocol, statistical analysis plan, table shell, case report form, data management plan, data verification plan, data transfer plan etc.
- Develop/validate and review of SDTM and ADaM data specifications.
- Create/validate CDISC compliant SDTM and ADaM datasets and generate tables, figures and data listings (TFLs) upon team's request.
- Prepare data submission packages including aCRF, xpt files, define.xml, reviewer's guides, computer programs and other documents, etc.
- Archive relevant documentation and deliverables.
- Works closely with other programmers to ensure the quality of all deliverables and project timelines are met.
- Ensure that all departmental standard operating procedures that govern any aspect of their work are adhered to.
- Contribute to process improvement initiatives.
Work Location:
Guangzhou, China or Suzhou, China
Qualifications:
Education: Bachelor's or higher degree in a statistic, mathematics, computer science, life sciences or health-related field. Experience in a pharma, biotech, or CRO environment is preferred.
Experience:
Knowledge/experience of data structures and relevant programming languages (e.g., SAS, R, Python, etc) for data manipulation and reporting. Knowledge of Visual Basic, Java, C#, or Perl programming language is preferred.
Language Requirement: Fluent in both written and verbal communication in English.
Other Skills:
- Strong capability on self-learning, independent thinking and problem solving.
- Good teaming collaboration. Able to work under high pressure.
Good interpersonal and communication skills.