Overview

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This is a Principal Statistical Programmer Analyst or Associate Manager level position in our highly regarded Statistical Programming department. Great opportunity to work remote for growing company in Life Science industry and work in supportive team environment on diverse client projects. Key responsibilities may include but are not limited to:

  • Programming edit checks for Data Management with SAS.
  • Create tables, listings and figures for clinical study report.
  • Annotated blank CRF (acrf.pdf) following FDA/CDISC or sponsor guidelines.
  • Create or QC SDTM specifications and SDTM datasets.
  • Create or QC ADaM specifications and ADaM datasets.
  • Create Study Data Reviewer’s Guide (cSDRG.pdf) and Analysis Data Reviewer’s Guide (ADRG.pdf).
  • Create define.xml or define.pdf following FDA/CDISC or sponsor guidelines.
  • Serve as project lead or team lead for the programming group.
  • Answer technical questions; Resolve or solve technical problems.
  • Work with global team or sponsors to coordinate project deliverables, timelines and resources.
  • For Programming Associate Manager level, manage programming/project team; work with management team, take initiatives and follow through to develop the programming team.
  • Be a role model for team members.

Qualifications

  • Bachelor’s degree in computer science, statistics or related scientific disciplines with 7-year clinical programming experience or Master’s degree in computer science, statistics or related disciplines with 6 year of clinical programming experience.
  • Working knowledge of ICH and 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.
  • Can communicate with global team independently.

PI

Tracking 9564

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