Biostatistician II (Oncology)

Location: Remote, United States

Salary: $125,040–$156,300 per year, with a discretionary annual bonus potentially available.

Company

hirify.global develops diagnostic devices and companion diagnostics for oncology and other applications.

What you will do

• Lead and execute the design and analysis of analytical and clinical validation studies for next-generation sequencing-based diagnostic devices.
• Develop protocols, statistical analysis plans, study reports, and data presentations.
• Create statistical and technical solutions for complex biostatistical problems and collaborate on study planning, data preparation, programming, analysis, and results presentation.
• Contribute to regulatory submissions and respond to review questions with guidance from senior team members.
• Represent biostatistics in cross-functional projects, maintain quality standards, and deliver accurate analyses on schedule.

Requirements

• Master’s degree in Statistics or Biostatistics with 4+ years of work experience, or PhD in Statistics or Biostatistics with 2+ years of experience.
• Strong programming skills in R.
• Experience as a biostatistician in the biopharmaceutical or medical diagnostics industry, academia, or government is preferred, including experience with clinical study design, clinical trials, diagnostic medicine, or medical device validation.
• Knowledge of relevant methods, including time-to-event and longitudinal data analysis, categorical and missing data analysis, real-world data analysis, or Bayesian methods.
• Knowledge of next-generation sequencing and genomics is preferred.
• Leadership, proactive strategy setting, prioritization, conflict resolution, and effective cross-functional collaboration skills.
• Excellent communication, presentation, and writing skills, with the ability to explain complex technical details clearly.
• Ability to work independently, manage multiple projects and deadlines, contribute to team projects, and maintain strong attention to detail and quality.
• Understanding of HIPAA and the importance of patient-data privacy, plus commitment to FMI’s values of Integrity, Courage, and Passion.

Culture & Benefits

• Full-time remote position based in the United States.
• Benefits are provided through hirify.global’s benefits program.
• Work involves collaboration across departments and with regulatory agencies, academic partners, and biopharmaceutical collaborators.