Biostatistician I (NGS/Oncology)

Location: Remote, United States

Salary: $103,700–$124,000 per year, with a discretionary annual bonus potentially available.

Company

Develops diagnostic devices and assays, including NGS-based companion diagnostics for oncology and other applications.

What you will do

• Design and analyze analytical and clinical validation studies for NGS-based diagnostic devices.
• Develop protocols, statistical analysis plans, study reports, and data presentations.
• Develop statistical and technical solutions to complex biostatistical problems.
• Collaborate with cross-functional teams on study design, data preparation, programming, analysis, and results presentation.
• Support regulatory submissions and respond to review questions with guidance from senior team members.
• Maintain biostatistical quality standards, accuracy, best practices, and delivery timelines.

Requirements

• Master’s degree in Statistics or Biostatistics plus 2+ years of work experience, or a PhD in Statistics or Biostatistics.
• Strong programming skills in R.
• Experience or knowledge in relevant areas such as clinical study design, clinical trials, time-to-event and longitudinal data analysis, statistical methods in diagnostic medicine, diagnostic device or companion diagnostic validation, categorical or missing data analysis, real-world data analysis, or Bayesian methods.
• Knowledge of NGS and genomics.
• Excellent communication, presentation, and writing skills, including the ability to explain complex technical details clearly.
• Independent thinking, successful independent work, and contributions to team projects.
• Ability to meet deadlines while managing multiple projects simultaneously.
• Strong interpersonal, collaboration, and problem-solving skills across departments.
• High attention to detail, focus on quality, and understanding of HIPAA and patient data privacy.

Nice to have

• PhD in Statistics or Biostatistics.
• Biostatistics work or internship experience in the biopharmaceutical or medical diagnostics industry, academia, or government, such as the FDA or NIH.

Culture & Benefits

• Full-time remote position in the United States.
• Benefits are available for the position.
• Commitment to the values of Integrity, Courage, and Passion.
• Compliance with attendance policies and established study delivery timelines.