Staff Biostatistician (Medtech)

TL;DR

Staff Biostatistician (Biostatistics): Supporting statistical study design and analysis for clinical studies of in vitro diagnostic products with an accent on regulatory submissions and FDA compliance. Focus on interpreting analysis results, designing innovative study protocols, and ensuring reporting accuracy for early cancer detection products.

Location: Remote (Must be based in the US)

Salary: $166,175 - $237,825

Company

hirify.global is a medtech company focused on changing the landscape of early cancer detection through innovative in vitro diagnostic products.

What you will do

• Lead biostatistical oversight for high-complexity clinical studies and provide technical expertise as a core team member.
• Develop statistical sections of study protocols and provide guidance on innovative study design and endpoint selection powering.
• Interpret analysis results and ensure reporting accuracy in study reports and regulatory documents.
• Manage operations with internal statistical programmers to ensure quality and timeliness of deliverables.
• Represent the Biostatistics department in interactions with regulatory authorities, such as the FDA, and during audits.
• Create and maintain SOPs, processes, and standards to ensure compliance and optimization of biostatistical workflows.

Requirements

• Location: Must be eligible to work under US Federal Employment Laws
• Master's degree or higher in Statistics, Biostatistics, or Math.
• 10+ years of lead project experience as a statistician on clinical trial projects.
• Strong programming skills using R (required) and proficiency with literate programming (R markdown/Sweave).
• Expert understanding of clinical trial design and biostatistics processes.
• Excellent written and verbal communication skills for interacting with all organizational levels.

Nice to have

• Ph.D. degree in Statistics, Biostatistics, or Math.
• Experience leading IVD clinical Biostatistics through FDA submission.
• Knowledge of CDISC requirements.
• Proficiency in Python.

Culture & Benefits

• Competitive base salary with eligibility for equity and cash bonuses.
• Full range of medical, financial, and other corporate benefits.
• Remote-first work arrangement.
• Commitment to diversity and equal-opportunity employment.