Biostatistician II

About the role

The organization operates in the precision medicine and diagnostic solutions industry, focusing on cancer and other diseases. It aims to address challenges in delivering high-quality, transformative diagnostic tools that support clinical and regulatory needs. The organization collaborates across departments to advance diagnostic assays with a patient-focused approach.

The Biostatistician II is responsible for providing statistical expertise to support the development, clinical and analytical validation, and regulatory approval of diagnostic devices. This role ensures study designs yield clear, interpretable results and timely delivery of high-quality analyses and reports. The position collaborates across teams to drive biostatistical strategies for evidence generation, contributing to regulatory submissions and scientific communications.

Responsibilities

• Lead design and data analysis of validation studies for next generation sequencing-based diagnostic devices.
• Develop innovative biostatistical solutions to complex problems.
• Represent the biostatistics team in cross-functional projects.
• Collaborate on study design, planning, data analysis, and result presentation.
• Contribute to regulatory submission components and respond to review questions.
• Maintain biostatistics quality standards and timely completion of analyses.
• Provide biostatistical interpretation and solutions across the organization.
• Perform other duties as assigned.

Requirements

• Master’s Degree in Statistics or Biostatistics with 4+ years of experience, or PhD with 2+ years.
• Strong programming skills in R.
• Preferred: PhD with experience in biopharmaceuticals, diagnostics, academia, or government.
• Knowledge of clinical study design, clinical trials, diagnostic statistical methods, and related areas.
• Leadership and effective cross-functional collaboration skills.
• Strong communication and writing abilities.
• Ability to manage multiple projects and meet deadlines.
• Attention to detail and commitment to data privacy and organizational values.

Pay

The expected salary range for this position based on the primary location of Remote is $125,040 - $156,300 per year. A discretionary annual bonus may be available based on individual and company performance.

Benefits

• Medical insurance
• Paid maternity leave
• Paid paternity leave