Biostatistician

Calyxo, Inc. is a medical device company headquartered in Pleasanton, California, USA. The company was founded in 2016 to address the profound need for improved kidney stone treatment. Kidney stone disease is a common, painful condition that consumes vast amounts of healthcare resources each year. Our team is led by executives and investors with a proven track record of commercializing paradigm-shifting devices to meet unmet needs within urology.

Are you ready to change the future of kidney stone treatment? We are seeking high achievers who want to be part of a dynamic team working in a fun, diverse atmosphere.

Summary :

We are seeking a strategic and solution-oriented biostatistician to lead and elevate the statistical strategy, analysis, and interpretation of data across the medical device product lifecycle - from pre-market clinical development to post-market surveillance. This role is pivotal in shaping evidence-generation strategies, ensuring scientific rigor, and enabling successful regulatory submissions.

The ideal candidate combines deep technical expertise with the ability to think critically, propose innovative approaches, and deliver high-impact, best-in-class results in a fast-paced, cross-functional environment. This individual will influence study design decisions, drive data-driven insights, and contribute to shaping the clinical and regulatory success of cutting-edge medical technologies.

This position requires a strong foundation in statistical methodologies, a strategic mindset, and the ability to effectively partner with R&D, Clinical Operations, Regulatory Affairs, and Quality Assurance teams.

In This Role, You Will :

Study Design & Strategic Analysis

• Lead the strategic planning and statistical design of clinical investigations (feasibility, pivotal, and PMCF), aligning with business objectives and regulatory expectations.
• Develop and own Statistical Analysis Plans (SAPs), randomization schemes, and interim / final analysis strategies, ensuring scientific robustness and regulatory compliance.
• Proactively identify opportunities to optimize study designs and analytical approaches, balancing innovation and risk.
• Champion fit-for-purpose methodologies that enhance evidence strength, efficiency, and interpretability.

Regulatory Strategy & Compliance

Scientific Communication

Post-Market & Real-World Evidence (RWE) Leadership

Cross-Functional Leadership & Strategic Consultation

Who You Will Report To :

Qualifications :

What Sets You Apart :

What We Offer :

At Calyxo, you will be part of a knowledgeable, high-achieving, experienced and fun team. You will work in a diverse work environment with experienced, proven leaders and have an opportunity to shape our company culture. You will experience constant learning and dynamic challenges to help you grow and be the best version of yourself.

We also offer an attractive compensation package, which includes :

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not only valued but also prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities, which strengthen our focus and fuel our growth.

Calyxo is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics

Legal authorization to work in the United States is required. In compliance with federal law, all persons hired will be required to verify their identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.

Disclaimer :

At Calyxo, we prioritize a transparent and structured interview process to ensure the best fit for both our candidates and our team. Please be aware of the following :

We appreciate your interest in joining Calyxo and look forward to getting to know you through our official channels.