Principal Statistical Programmer - Katalyst Healthcares & Life Sciences
South Plainfield, NJ 07080
About the Job
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.
- Bachelor's degree in computer science (CS), statistics, or related scientific disciplines with 8 yrs. of clinical programming (CDISC) experience; (or) Master's degree in CS, statistics or related disciplines with 6 yrs. of clinical programming (CDISC) experience.
- Need to have Oncology/Hematology TA 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.
Source : Katalyst Healthcares & Life Sciences
