Senior Manager, Programming

Role Overview

• Serve as a programming point of contact between SMPA and SMP
• Facilitate communication and collaboration between SMP programming and SMPA programming, biostatistics, data management, clinical research, clinical operations, medical writing and CROs
• Lead and manage the contactor programmers and provide programming support to clinical trials for regulatory submissions and publications, and ad hoc or post hoc analyses
• Generate SDTM/ADaM datasets, listings, tables and figures, as well as supporting documentation (i.e. define.xml) for clinical trials
• Function as lead (or co-lead together with SMP) programmer on single or multi-protocol projects and participate in project team meetings

Requirements

• Bachelor’s or Master’s degree
• 5-7 years programming experience in the pharmaceutical industry or equivalent experience
• Education in statistics is highly desirable
• Proficiency in SAS/BASE, STAT, GRAPHICS and MACRO
• Experience creating/reviewing/validating CDISC SDTM and ADaM datasets
• Demonstrated NDA, sNDA submissions and ISS/ISE experience

Benefits

• Merit-based salary increases
• Short incentive plan participation
• Eligibility for our 401(k) plan
• Medical, dental, vision, life and disability insurances
• Unlimited paid time off
• 11 paid holidays
• Additional time off for shut-down period during the last week of December
• 80 hours of paid sick time upon hire and each year thereafter