⏳ Experience: 10+ year clinical programming experience
🪄 Skills: SAS EGData modelingData management
Requirements:
Bachelor’s degree in computer science, statistics or related scientific disciplines with 10+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 9+ year of clinical programming experience;
Working knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology
Good understanding of clinical drug development process
Detail oriented
Strong communication skills and coordination skills
Good leadership skills
Responsibilities:
Programming edit checks for Data Management with SAS.
Create tables, listings and figures for clinical study report.
Independently annotated blank CRF (acrf.pdf) with appropriate tools per FDA or CDISC guidelines.
Create or QC SDTM specifications and SDTM datasets.
Create or QC ADaM specifications and ADaM datasets.
Create or QC define.xml or define.pdf
Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf)
Serve as team leader for one/more Programming groups.
Independently coordinate and manage the preparation, execution, reporting and documentation of projects within a Programming group.
Manage and coordinate the integration of data across studies in support if ISS and ISE and electronic submission deliverables.
Following industry standards and be a mentor to other Programming leads or managers.
Manage programming team. Take initiatives and follow through to develop the Programming team. Dare to lead.