Lead Biostatistical Programmer for Clinical Trials

1 week ago


Canada Warman O'Brien Full time

We are partnered with a small Contract Research Organization (CRO) that is experiencing significant growth within the Biometrics department. The role of Senior Statistical Programmer is key to this expansion.

The Job

As a Senior Statistical Programmer, you will be responsible for leading high-impact projects, tackling complex statistical programming tasks, and managing project timelines. You will work directly with clients and regulatory agencies to ensure data quality and deliver programming solutions for clinical trials. Additionally, you will have the opportunity to mentor junior team members, contribute to regulatory submissions, and develop new programming tools.

Main Responsibilities:
  • Lead statistical programming for complex projects, 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, adhering 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.

What We're Looking For:

  • A Master's or Ph.D. in Statistics, Biostatistics, Epidemiology, or Computer Science.
  • 6+ years of clinical trial statistical programming experience with an advanced degree, or 8+ years with a Bachelor's degree.
  • Experience working with clinical trial data, SDTM/ADaM datasets, and regulatory submissions.

Salary Range: $120,000 - $180,000 per year, depending on experience.



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