Statistical Programmer II

Tasks

• Coordinate project start-up activities
• Create project documentation
• Develop derived datasets
• Ensure compliance with ICH-GCP and regulations
• Maintain derived dataset specifications
• Maintain regulatory knowledge
• Maintain study documentation per SOPs and guidelines
• Participate in audits and regulatory inspections
• Participate in process and quality improvement
• Perform quality control on derived outputs
• Produce SDTM ADaM tables figures data listings
• Provide training and mentorship

Perks/Benefits

• N/A

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Electronic submissions | ICH GCP | Part 11 | QC | S&OP | SAS | SDTM