Principal, Statistical Programmer

Tasks

• Communicate with internal and external project teams
• Create and validate randomization lists
• Ensure compliance to SOPs
• Identify efficiency and process improvements
• Identify project scope changes and delivery risks
• Implement new statistical programming techniques tools and solutions
• Lead initiatives to improve department processes
• Lead statistical programming activities on clinical projects
• Mentor statistical programming team members
• Prepare and perform training on statistical programming techniques
• Produce and review CDISC documentation
• Report deviations KPIs customer complaints and CAPAs
• Specify program and validate CDISC ADaM datasets
• Specify program and validate CDISC SDTM datasets
• Specify program and validate statistical analysis results
• Supervise tasks by statistical programmers
• Support quality assurance audits

Perks/Benefits

• N/A

Skills/Tech-stack

CAPA management | CDISC ADaM | CDISC SDTM | Clinical Research | Clinical data | Clinical data standards | Data Standards | Quality Assurance | R | Randomization lists | SAS | SOP compliance | Statistical Analysis