Principal Statistical Programmer Analyst
The Principal Statistical Programmer Analyst is accountable for the quality, timely, and efficient delivery of projects, programming work, and good information management. This position requires profound programming experience and excellent industry knowledge to independently lead the implementation of programming activities as well as lead other programmers. It is a leadership role that can have a project or technical focus. It will provide subject matter expertise within the programming discipline as an expert within their own field, acts as a specialist within cross-functional teams to deliver continuous improvement. Must have experience working with oncology trials.
Main Job Tasks and Responsibilities:
- Leads and directs the full scope of project delivery and/or leads a technical project within the TA/Drug Project/study/function
- Leads Implementation of statistical programming aspects of the protocol or clinical development program
- Responsible for the high quality of all project deliverables, holding partners and providers accountable for the quality of their deliverable and/or technical subject matter expert for aspect(s) of the TA, Project, or function Leads or contribute to cross-functional administrative or process improvement initiative(s)
- Drives the development of best practices to improve quality, efficiency, and/or effectiveness within the function. Drives standards development and implementation.
- Manages and escalates risk in complicated or novel situations within their study and/or projects.
- Provides Programming expertise to the team
- Provides tactical input and/or drives ideas and improvements
- Contributes to the function by supporting recruiting and/or providing training and mentorship
- Identifies opportunities to improve methodology and provides practical solutions for problems
- Influences stakeholders by providing subject matter expertise on programming-related items
- Ensures compliance with standards and automation usage
- Employs all project management practices in managing drug or technical projects
- Provides input to capacity management for all projects in scope
- Maintains expertise in the latest industry and regulatory requirements to stay current
Education and Experience:
- Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 years of clinical programming experience; Master's degree in CS, statistics, or related disciplines with 7 years of clinical programming 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
- Detail oriented
- Strong communication skills and coordination skills
- Can communicate with global teams independently
- Experience with oncology trials
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