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Warman O'Brien

Lead Statistical Programmer

United States

about 1 month ago
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Summary

Senior/Principal Statistical Programmer | Small CRO | Remote/Hybrid


We're partnered with a small CRO who are experiencing a large amount of growth within Biometrics.


The Role: As a Senior Statistical Programmer, you'll lead high-impact projects, tackling complex statistical programming tasks and managing project timelines. You'll work directly with clients and regulatory agencies, ensuring data quality and delivering programming solutions for clinical trials. You’ll also have the chance to mentor junior team members, contribute to regulatory submissions, and develop new programming tools.


Key Responsibilities:

  • Lead statistical programming for complex projects, solving intricate challenges while ensuring project delivery meets quality standards.
  • Collaborate with clients, providing programming oversight, project estimates, and participating in bid defenses.
  • Contribute to regulatory submissions and represent the company in regulatory discussions.
  • Create and validate SDTM and ADaM dataset specifications, ensuring adherence to SOPs.
  • Program and validate datasets, ensuring accuracy and data integrity.
  • Mentor junior programmers and lead project teams, fostering development and collaboration.
  • Innovate by developing macros, utilities, and tools to enhance efficiency.
  • Implement data integrity checks, ensuring scientific accuracy and quality.


Qualifications:

  • Master’s or Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Science.
  • 6+ years of clinical trial statistical programming experience with a Masters Degree or higher in a Statistical related subject.
  • Experience working with clinical trial data, SDTM/ADaM datasets, and regulatory submissions.


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