Biostatistician

Roche•Indianapolis, IN
•$102,500 - $190,300

About The Position

The Biostatistician partners with clinical investigators and research partners to design robust clinical studies, select appropriate statistical methodologies, and determine suitable sample sizes to substantiate clinical utility. The role authors statistical analysis plans and statistical reports for health authority review and scientific evaluation, performs analyses, coordinates randomization and blinding procedures, and oversees peer quality reviews to maintain data integrity. The position develops and applies statistical methods and study design improvements to address technical challenges in diagnostic development. It takes ownership of major diagnostic project deliverables, mentors team members, and represents the team’s scientific work through publications, conference presentations, and cross-functional workshops. The role requires close collaboration across multidisciplinary teams and clear communication of statistical concepts to scientific audiences.

Requirements

  • Master’s degree in Statistics, Biostatistics, or a closely related quantitative field with 9 or more years of relevant experience, or a PhD with 6 or more years of relevant experience.
  • Hands-on proficiency in statistical programming using SAS or R.
  • Experience in statistical analysis and reporting for diagnostic validation or clinical studies.
  • Practical understanding of regulatory considerations for in vitro diagnostic devices, including sensitivity, specificity, agreement rates, and reproducibility evaluations.
  • Ability to work collaboratively in multidisciplinary teams, coordinating cross-functional alignment and quality control.
  • Ability to communicate statistical concepts clearly to diverse scientific audiences.

Nice To Haves

  • Technical presentations, white papers, or publications.

Responsibilities

  • Collaborate with clinical investigators and research partners to design clinical studies, select statistical methodologies, and establish sample sizes.
  • Write statistical analysis plans and statistical reports for health authority review and scientific evaluation.
  • Perform data analyses and coordinate sample randomization and blinding procedures.
  • Oversee peer quality reviews to uphold data integrity.
  • Identify, develop, and apply statistical solutions and study design improvements for diagnostic development challenges.
  • Own major diagnostic project deliverables and coach team members.
  • Represent the team’s scientific contributions through technical publications, conference presentations, and cross-functional workshops.

Benefits

  • A discretionary annual bonus may be available based on individual and company performance.
  • Benefits are referenced at a provided link; specific benefits are not listed.
  • Relocation benefits are not available for this position.
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