Note: The job is a remote job and is open to candidates in USA. ClinChoice is hiring a Principal Statistical Programmer Consultant to work with one of its clients. The role supports and leads programming activities for clinical studies and projects, delivering high-quality statistical programming and documentation while coordinating with study team members.

Responsibilities

• Responsible for supporting the Programming deliveries of a clinical study or project
• Implements statistical programming aspects of the protocol and the clinical development program
• Ensures high quality is built into own deliverables and the quality delivered by other programmers
• Programs independently with high efficiency and quality
• Writes and/or implements specifications and oversees completeness of relevant documentation
• Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function
• Ensures compliance with standards and automation usage
• Plans and support team activities and tasks
• Communicates and escalates risks within the assigned studies and/or projects
• Works proactively with study team members including but not limited to the Statistician, Lead Programmer, Data Manager and Study Leader

Skills

• Confident candidates with the ability to work independently
• High technical skills and thorough industry knowledge
• Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 5 yrs. of clinical programming (CDISC) experience; Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience
• Working knowledge of ICH and Good Clinical Practices, Clinical research, Clinical trial process, and related regulatory requirements and terminology
• Good understanding of the clinical drug development process
• Strong communication skills and coordination skills
• Current knowledge of technical and regulatory requirements relevant for the role
• Ability to proactively manage concurrent activities within a project
• Proficient ability to influence relevant stakeholders on programming-related items

Benefits

• Career opportunities through working for a global CRO
• Professional development
• Supportive culture
• Continuous training to maintain competence and expertise and provide personnel with tools for internal and client processes
• Diversity and inclusivity

Company Overview

Company H1B Sponsorship