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 position involves collaboration with statistical programming, statistics, regulatory, and other project stakeholders to ensure data conformance, traceability, and quality assurance.
The company offers a comprehensive benefits package including medical, dental, vision, retirement benefits, paid holidays, vacation, and opportunities for bonuses 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
Skills & Requirements
Must-have
SAS programming in clinical trials
Submission data standards planning
Regulatory application submissions
Statistical programming collaboration
Quality assurance of deliverables
Project management skills
Nice-to-have
Experience with SDTM and ADaM standards
Technical writing skills
Process improvement initiatives
Cross-cultural collaboration
Use of SAS, R, and Python
Participation in professional societies
Key Requirements
BA/BS plus 5-9 years SAS programming experience
MS plus 3-7 years SAS programming experience
Experience with US and worldwide regulatory submissions
Knowledge of clinical data standards (CDISC, SDTM, ADaM, HL7)
Experience with electronic submission deliverables