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