The Senior 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 Senior 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 role involves collaboration with statistical programming, statistics, regulatory, and other project stakeholders to ensure traceability, quality assurance, data conformance, and data fitness in electronic submissions.
The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and sick days, along with eligibility for annual bonus and long-term incentives.
Matching Summary
The Senior 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: $117,000.00 - $184,200.00; 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 expertise
Regulatory application submissions
Statistical programming deliverables
Project management skills
Technical writing skills
Hybrid work model
Nice-to-have
Process improvement initiatives
Cross-cultural collaboration
Knowledge of SDLC and SOPs
Experience with R and Python
Participation in professional societies
Strategic thinking abilities
Use of Microsoft Project
Key Requirements
BA/BS plus 5-9 years SAS experience
MS plus 3-7 years SAS experience
Experience with US and worldwide regulatory submissions
In-depth knowledge of CDISC standards
Proficiency in diverse data collection methods
Experience with electronic submission deliverables