Senior Manager, Statistical Programming (Remote)

This is Senior Manager level position for Statistical Programming. Key responsibilities and skills include, but are not limited to:

  • 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.
  • Be a role model for team members.

Qualifications

  • Bachelor’s degree in computer science, statistics or related scientific disciplines with 9+ years clinical programming experience;or Master’s degree in computer science, statistics or related disciplines with 8+ years 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


ClinChoice is an Equal Opportunity Employer / Committed to Diversity

 

PI131553753