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 offers a hybrid work model with three days on-site per week and includes a comprehensive benefits package covering medical, dental, vision, retirement, paid holidays, and vacation.
The company embraces diversity and inclusion, encouraging collaboration among people with diverse experiences and backgrounds to foster innovation.
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
Clinical data standards implementation
Electronic submission deliverables
Project management skills
Regulatory submission experience
Statistical programming
Stakeholder collaboration
Nice-to-have
Process improvement initiatives
Technical writing skills
Cross-cultural collaboration
Knowledge of SDLC and SOPs
Experience with R and Python
Use of Microsoft Project
Participation in professional societies
Key Requirements
BA/BS with 5-9 years SAS experience or MS with 3-7 years SAS experience
US and/or worldwide drug or vaccine regulatory submission experience
In-depth knowledge of CDISC standards (SDTM, ADaM, CDASH)
Experience with electronic submission deliverables (SDRG, ADRG, Define.xml)