The Associate Principal Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions 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 application submissions of drug and vaccine clinical development projects.
The position involves collaboration with statistical programming, statistics, regulatory, and other project stakeholders to ensure efficient execution of project plans with timely and high quality deliverables.
The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days.
Matching Summary
The Associate Principal Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory application submissions 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
SAS programming in clinical trials
Submission data standards SDTM ADaM
Statistical programming leadership
Regulatory submission deliverables
Python and SAS technical skills
Project management skills
Electronic submission process improvement
Nice-to-have
Technical writing skills
Mentoring and guidance experience
Experience with global outsource partners
Cross-cultural collaboration
Process improvement expertise
Participation in industry conferences
Knowledge of SOPs and SDLC
Key Requirements
BA/BS plus 9 years SAS programming experience
MS plus 7 years SAS programming experience
US and/or worldwide drug regulatory submission experience