Statistical Programmer II

Tasks

• Assist production and QC of derived dataset specifications
• Check own work to ensure first time quality
• Coordinate project start-up activities
• Create derived datasets SDTM and ADaM
• Create global programs and tracking spreadsheets
• Deliver high quality statistical programming services
• Ensure compliance with SOPs and guidelines and ICH GCP
• Interpret regulatory requirements for technical standards
• Maintain study supporting documentation to ensure traceability
• Participate in internal and external audits and regulatory inspections
• Participate in process and quality improvement initiatives
• Perform QC for low to medium complexity derived datasets tables figures and data listings
• Produce tables figures and data listings
• Provide training and mentorship to staff and project teams

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