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 hybrid work model with three days on-site per week and includes a comprehensive benefits package with medical, dental, vision, retirement, and paid time off.
The successful candidate will be eligible for an annual bonus and long-term incentives, and the role includes collaboration with statistical programming, statistics, regulatory, and other project stakeholders.
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, and sick days
Skills & Requirements
Must-have
SAS programming in clinical trials
Submission data standards SDTM and ADaM
Statistical programming leadership
Regulatory submission deliverables
Project management skills
Python and SAS technical knowledge
Electronic submission process improvement
Nice-to-have
Technical writing skills
Mentoring and guidance experience
Cross-cultural collaboration
Process improvement expertise
Experience with Microsoft Project
Active in professional societies
Familiarity with clinical data management
Key Requirements
BA/BS plus 9 years SAS programming experience
MS plus 7 years SAS programming experience
US and/or worldwide regulatory submission leadership
Experience with CDISC standards and Define.XML
Ability to provide technical and programming guidance