Statistical Programmer II Guangzhou

Tasks

• Check own work for first-time quality
• Coordinate project start-up activities
• Create global programs and track documentation
• Develop SAS knowledge and regulatory knowledge
• Ensure compliance with SOPs and guidelines
• Generate SDTM and ADaM datasets
• Maintain regulatory compliance for submissions
• Maintain supporting study documentation
• Participate in internal external audits and regulatory inspections
• Participate in process and quality improvement initiatives
• Perform quality control of derived datasets
• Produce tables figures and data listings
• Provide training and mentorship
• Use efficient programming techniques to produce derived datasets

Perks/Benefits

• N/A

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Clinical data | Clinical data management | Data Management | Data Quality | Data quality control | ICH GCP | Part 11 | Process Improvement | Quality Control | Quality Improvement | SAS | SDTM