#766-Sr Principal Statistical Programmer-Remote(Permanent role)

Job Description

ClinChoice is seeking a Sr Principal Statistical Programmer to join their in-house team on a permanent, remote basis. ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative “one-team” culture. The Sr Principal Statistical Programmer will be responsible for various tasks related to clinical study reporting and data management.Role involves:

• Programming edit checks for Data Management with SAS.
• Creating tables, listings, and figures for clinical study reports.
• Independently annotating blank CRF with appropriate tools per FDA or CDISC guidelines.
• Creating or QC SDTM specifications and SDTM datasets.
• Creating or QC ADaM specifications and ADaM datasets.
• Creating or QC define.xml or define.pdf.
• Creating Study Data Reviewer’s Guide and Analysis Data Reviewer’s Guide.
• Serving as team leader for one/more Programming groups.
• Independently coordinating and managing the preparation, execution, reporting, and documentation of projects within a Programming group.
• Managing and coordinating 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.
• Managing programming team. Taking initiatives and following through to develop the Programming team.

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 and coordination skills.
• Good leadership skills.

ClinChoice offers:

• Professional development opportunities.
• Excellent work-life balance.
• A quality-focused, collaborative “one-team” culture.