Artera.net

Senior Biostatistician

Artera.net

full-time

Posted on:

Location: 🇺🇸 United States

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Salary

💰 $140,000 - $180,000 per year

Job Level

Senior

About the role

  • Provide statistical leadership across Artera’s research and development pipeline and product lifecycle — spanning data acquisition, study design, model and product validation, regulatory and reimbursement submissions, and post-market evidence generation.
  • Collaborate with R&D teams on model development strategies, providing statistical expertise on study design, validation approaches, and other key considerations that ensure scientific rigor and product credibility.
  • Lead the application of rigorous statistical methodology, ensuring robustness, reproducibility, and high-quality evidence to support product development and research initiatives.
  • Guide the development and review of statistical content for protocols, analysis plans, study reports, regulatory submissions, and peer-reviewed publications.
  • Drive data governance, validation, and documentation practices that ensure compliance and support regulatory, reimbursement, and external stakeholder requirements.
  • Represent Biostatistics as a scientific leader in cross-functional and external collaborations, communicating complex statistical concepts to diverse scientific, clinical, and business audiences.

Requirements

  • Master’s degree or higher in Biostatistics, Statistics, or a related quantitative field.
  • Strong working knowledge of statistical methods for clinical studies (e.g., clinical trials, validation studies).
  • Skilled in R for statistical programming, simulation, and reproducible research workflows.
  • Minimum 5 years of experience as a biostatistician, or equivalent combination of education and experience; experience as an industry biostatistician in biomarker, medical device, or biotech/biopharma preferred.
  • Experience drafting and reviewing statistical sections of clinical study protocols, analysis plans, and regulatory documents.
  • Demonstrated ability to communicate statistical concepts effectively to non-statistical audiences.
  • (Nice-to-Haves) Familiarity with AI and machine learning methods, particularly in predictive and prognostic model development and validation.
  • (Nice-to-Haves) Strong publication record and experience contributing to peer-reviewed manuscripts and conference presentations.
  • (Nice-to-Haves) Knowledge and hands-on experience with regulatory submissions.
  • (Nice-to-Haves) Experience supporting reimbursement/evidence generation submissions for payer decision-making.
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