Principal Statistical Programmer Analyst, Principle Data Scientist

Responsibilities

Primary Responsibilities:

This is Senior Manager level position for Statistical Programming.  Key responsibilities and skills may 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+ year clinical programming experience; Master’s degree in computer science, statistics or related disciplines with 8+ 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