Statistical Programmer I/II

Tasks

• Apply quality checks to ensure first time quality
• Coordinate project start-up activities
• Create derived datasets
• Deliver statistical programming services
• Ensure compliance with ICH GCP and 21 CFR Part 11
• Ensure compliance with SOPs and guidelines
• Generate SDTM and ADaM datasets
• Maintain and expand regulatory knowledge
• Maintain regulatory and technical documentation
• Participate in internal and external audits
• Participate in process and quality improvement initiatives
• Produce tables figures and data listings
• Provide training and mentorship
• Support derived dataset specifications production and QC
• Support regulatory inspections
• Track project documentation and spreadsheets

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 | SAS | SDTM | SOPs