The Senior 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 Senior 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 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 sick days.
Matching Summary
The Senior 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: $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
Project management skills
Statistical programming deliverables
Quality assurance and process compliance
Nice-to-have
Experience with SDTM and ADaM standards
Technical writing skills
Global outsource partner collaboration
Knowledge of SOPs and SDLC
Cross-cultural work experience
Use of SAS, R, and Python
Participation in professional societies
Key Requirements
BA/BS plus 5-9 years SAS experience
MS plus 3-7 years SAS experience
US and/or worldwide regulatory submission experience
Experience with CDISC standards and electronic submissions