Statistical Programmer II

Tasks

• Assist in project start-up coordination
• Assist production and QC of derived dataset specifications
• Check own work to ensure first time quality
• Create ADaM tables figures and data listings
• Create SDTM tables figures and data listings
• Create global program documentation
• Deliver high quality statistical programming services
• Ensure compliance with SOPs guidelines ICH GCP and regulations
• Maintain supporting study documentation per SOPs and guidelines
• Participate in internal and external audits
• Perform QC for low to medium complexity derived datasets
• Proactively participate in process and quality improvement initiatives
• Produce derived datasets
• Support regulatory submissions documentation
• Track spreadsheets and required documentation

Perks/Benefits

• N/A

Skills/Tech-stack

21 CFR | 21 CFR Part 11 | ADaM | CDISC | CFR Part 11 | Data submission | Documentation Management | Electronic Data | Electronic data submission | ICH GCP | Part 11 | Process Improvement | Quality Control | SAS | SDTM