The role involves leading clinical studies and managing or training other team members within the statistical programming department
Job Summary
The role involves leading clinical studies and managing or training other team members within the statistical programming department.
Candidates must possess solid knowledge of CDISC standards and FDA submission requirements to generate files like Define.xml and Reviewer's Guides.
The position offers a base salary range of $168,000.00 to $210,000.00 along with comprehensive benefits including 401(k) and flexible time off.
Matching Summary
The role involves leading clinical studies and managing or training other team members within the statistical programming department.
Salary
Base: $168,000.00 - $210,000.00; Bonus/Equity: Short incentive plan participation; Benefits: 401(k), medical, dental, vision, life, disability, paid time off
Skills & Requirements
Must-have
8+ years pharmaceutical programming experience
2+ years people management experience
FDA submission experience required
Expertise in CDISC SDTM and ADaM standards
Advanced Base SAS, Macros, Graph, STAT, SQL, ODS skills
Nice-to-have
Experience with R Shiny tools
Knowledge of integrated summaries ISE/ISS
Ability to create efficiency improvement tools
Cross-functional collaboration skills
Coaching and mentoring capabilities
Key Requirements
Minimum 8 years pharmaceutical/biotech programming experience
Two years of people management experience
BS/MS in Statistics, Math, or Scientific Discipline