5 years sas programming experience in clinical trials
Cdisc sdtm and adam submission standards expertise
Electronic submission deliverable development experience
The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications
Job Summary
The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications.
This role involves continuous improvement of electronic submission processes while ensuring traceability, quality assurance, and data conformance.
The position offers a comprehensive benefits package including medical, dental, vision, 401(k), and eligibility for annual bonuses and long-term incentives.
Matching Summary
The Senior Statistical Programmer provides oversight and quality management of submission data standard deliverables for worldwide regulatory applications.
Salary
Base: $117,000.00 - $184,200.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation
Skills & Requirements
Must-have
5 years SAS programming experience in clinical trials
CDISC SDTM and ADaM submission standards expertise
Electronic submission deliverable development experience
Pinnacle 21 Enterprise tool proficiency
FDA regulatory agency meeting participation
Nice-to-have
Hands-on experience with R and Python for data analysis
Strategic thinking to turn strategy into tactical activities
Experience managing global outsource partner programming staff
Active membership in professional societies
Ability to work across cultures and geographies
Key Requirements
BA/BS plus 5 years or MS plus 3 years SAS programming experience
US and/or worldwide drug or vaccine regulatory application submission experience
Demonstrated success in assurance of deliverable quality and process compliance