The role involves leading clinical studies and managing team members while providing training to enhance programming value across therapeutic areas
Job Summary
The role involves leading clinical studies and managing team members while providing training to enhance programming value across therapeutic areas.
Candidates must possess solid knowledge of CDISC standards and FDA submission requirements to generate regulatory files like Define.xml and Reviewer's Guides.
The position offers a competitive 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 team members while providing training to enhance programming value across therapeutic areas.
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
CDISC SDTM and ADaM knowledge
Base SAS, Macros, Graph, Stat, SQL proficiency
Nice-to-have
R Shiny software experience
Integrated summaries (ISE/ISS) expertise
Cross-functional collaboration skills
Coaching and mentoring abilities
Tool creation for efficiency
Key Requirements
Minimum 8 years pharmaceutical programming experience
Two years of people management experience
BS/MS in Statistics, Math or Scientific Discipline