About The Position

ClinChoice is searching for a Principal Statistical Programmer Consultant to join one of our clients. This is a client-facing role where confidence and the ability to work independently are key, while also establishing a high-trust environment with the client’s counterparts. The Principal Statistical Programmer Consultant is a delivery-focused role who works under the leadership, oversight, and direction of a Programming team leader to lead and/or support aspects of the programming effort to deliver technical programming and information components of a project. This position requires high technical skills and thorough industry knowledge to independently perform the Programming tasks.

Requirements

  • 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.
  • Oncology 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 items

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.
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