Senior Statistical Programmer Consultant

C
ClinChoiceClinical Research, Oncology
Remote in USFull-TimeSenior
Salary not disclosed
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Job Details

Experience
Bachelor’s degree with 5 yrs. of clinical programming (CDISC) experience; Master’s degree with 6 yrs. of clinical programming (CDISC) experience.

Requirements

  • Bachelor’s degree in CS, statistics, or related scientific disciplines with 5+ years of clinical programming (CDISC) experience.
  • Master’s degree in CS, statistics, or related disciplines with 6+ years of clinical programming (CDISC) experience.
  • Oncology therapeutic area experience.
  • Working knowledge of ICH and Good Clinical Practices (GCP).
  • Understanding of clinical research, clinical trial processes, and related regulatory requirements.
  • Current knowledge of technical and regulatory requirements.
  • Ability to work independently while establishing high-trust client relationships.
  • Strong communication and coordination skills.
  • Ability to proactively manage concurrent project activities.
  • Proficient ability to influence stakeholders on programming-related items.

Responsibilities

  • Support the Programming deliveries of a clinical study or project.
  • Implement statistical programming aspects of the protocol and the clinical development program.
  • Ensure high quality is built into own deliverables and the quality delivered by other programmers.
  • Program independently with high efficiency and quality.
  • Write and/or implement specifications and oversee completeness of relevant documentation.
  • Contribute to the development of best practices to improve quality, efficiency, and effectiveness within the function.
  • Ensure compliance with standards and automation usage.
  • Plan and support team activities and tasks.
  • Communicate and escalate risks within the assigned studies and/or projects.
  • Work proactively with study team members including the Statistician, Lead Programmer, Data Manager and Study Leader.
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