Principal Biostatistician

Posted 24 January 2025
LocationSalt Lake City
Job type Permanent
Reference209370
Contact NameTyler Abrams

Job description

Position Overview
We are seeking a highly skilled Principal Biostatistician to join our client’s team. This individual will collaborate with cross-functional teams to develop clinical evidence for advanced molecular tests used in oncology, supporting screening, diagnosis, prognosis, monitoring, and therapy selection.

Compensation for this role is competitive to industry standards with a range of 

Key Responsibilities

  • Serve as the primary representative for the biostatistical function, providing strategic input and innovative solutions to support product objectives.
  • Design and provide guidance for clinical validity, clinical utility, health economics, and clinical experience studies by:
  • Evaluating evidentiary requirements.
  • Contributing to proposals, regulatory submissions, and study protocols, including endpoint selection, power/sample size calculations, and analysis planning.
  • Reviewing case report forms and data transfer requirements.
  • Authoring and reviewing statistical analysis plans.
  • Utilize advanced statistical methods and programming to:
  • Monitor clinical data quality.
  • Develop evidence for clinical predictive models.
  • Conduct simulation studies.
  • Communicate statistical findings through a variety of formats, including reports, presentations, regulatory submissions, and marketing collateral.
  • Evaluate study designs, analysis plans for investigator-sponsored studies, and evidence for external molecular tests.
  • Assess the applicability of novel statistical techniques.

    Minimum Qualifications

    • Master’s degree in Biostatistics or a closely related field with 9–14 years of relevant experience.
    • Proficiency in theoretical and applied statistics.
    • Expertise in statistical programming tools such as SAS, R, or Python.
    • Strong verbal, written, and graphical communication skills.
    • Proven ability to work both independently and collaboratively within a cross-functional team.
    • Authorization to work in the United States without sponsorship.

    Preferred Qualifications

    • Experience in molecular diagnostics, drug development, medical device development, epidemiology, public health, or healthcare.
    • Familiarity with product development for regulatory approvals (e.g., FDA).
    • Experience working within regulated environments, such as FDA or EU frameworks.