The Associate Principal Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications of drug and vaccine clinical development projects
Job Summary
The Associate Principal Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications of drug and vaccine clinical development projects.
The position offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days.
Employees in office-based U.S. positions will work a hybrid schedule with three days on-site and two days remote per week, effective September 5, 2023.
Matching Summary
The Associate Principal Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications of drug and vaccine clinical development projects.
Salary
Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, retirement, paid holidays, vacation, sick days
Skills & Requirements
Must-have
Submission data standards planning
SAS and Python programming
Regulatory submission deliverables
Project management skills
CDISC standards (SDTM, ADaM)
Quality assurance and process compliance
Nice-to-have
Technical writing skills
Mentoring and guidance
Process improvement experience
Cross-cultural collaboration
Experience with Microsoft Project
Participation in industry conferences
Key Requirements
BA/BS plus 9 years SAS programming experience
MS plus 7 years SAS programming experience
Experience with US and worldwide regulatory submissions
Leadership level experience in drug or vaccine submissions