United States onlyAbout Us: Artera is an AI startup that develops medical artificial intelligence tests to personalize therapy for cancer patients. Artera is on a mission to personalize medical decisions for patients and physicians on a global scale.
As a Senior Biostatistician at Artera, you will provide statistical and scientific leadership across clinical and translational studies that advance our AI-driven products. You will collaborate with Biostatistics, cross-functional teams, and external partners to ensure rigorous statistical methodology for product development, support regulatory and reimbursement submissions, and contribute to post-market evidence generation. This role combines hands-on analysis with opportunities to guide strategy and best practices in Biostatistics.
Roles and Responsibilities:
- 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.
Skills & Qualifications:
- Must-Haves:
- 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.
- Strong publication record and experience contributing to peer-reviewed manuscripts and conference presentations.
- Knowledge and hands-on experience with regulatory submissions.
- Experience supporting reimbursement/evidence generation submissions for payer decision-making.
Equal Employee Opportunity: At Artera, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients and physicians. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.
