Hengrui Pharma is hiring a Statistical Programming Management Trainee to support clinical study data programming and review. The role includes developing and validating CDISC-compliant datasets, preparing submission packages, and contributing to quality and process improvement.
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
Utilize AI tools to support SAS/R programming, code review, and double-programming QC checks, and rigorously review AI-generated content to ensure compliance with CDISC standards
Perform other reasonable duties as assigned by the supervisor
Qualification
Required
Bachelor's or higher degree in a statistic, mathematics, computer science, life sciences or health-related field
Knowledge/experience of data structures and relevant programming languages (e.g., SAS, R, Python, etc) for data manipulation and reporting
Able to use AI tools to build project-level medical data review platforms or efficiency tools, and assist other departments with implementation when needed
Fluent in both written and verbal communication in English
Preferred
Knowledge of Visual Basic, Java, C#, or Perl programming language
