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