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.
- 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