Biostatistician Pleasanton, CA

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 astrategic and solution-oriented biostatisticianto 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 thestrategic planning and statistical designof clinical investigations (feasibility pivotal and PMCF) aligning with business objectives and regulatory expectations.
• Develop and ownStatistical 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.
• Championfit-for-purpose methodologiesthat enhance evidence strength efficiency and interpretability.

Regulatory Strategy & Compliance

• Serve as thestatistical leadfor global regulatory submissions (FDA EMA PMDA Notified Bodies) including 510(k) PMA De Novo and CE Mark dossiers.
• Drive the creation of high-quality statistical deliverables for inclusion in CSRs CERs and SSCPs that communicate results clearly and effectively to diverse stakeholders.
• Ensure full compliance withGCP ISO 14155 ICH E9/E10 and other applicable standards while staying current with evolving regulatory trends and expectations.

Scientific Communication

• Collaborate on the development ofscientific publications abstracts posters and presentations based on clinical study data.
• Assist in creatingclear compelling data visualizationsand summaries for both internal and external stakeholders.

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

• Support the analysis ofreal-world data (RWD)and Post-Market Surveillance (PMS) data for ongoing device safety performance monitoring and regulatory requirements.
• Utilize advanced statistical modeling to support benefit-risk assessments trend analyses and safety signal detection.
• Contribute strategically toevidence synthesis and lifecycle management supporting product updates indications expansions and labeling claims.

Cross-Functional Leadership & Strategic Consultation

• Act as a key statistical thought partner to Clinical Operations Regulatory Affairs R&D and Quality teams.
• Aid in translation of complex statistical results into clearactionable insightsfor diverse technical and non-technical audiences.
• Providestrategic inputon clinical development plans regulatory strategies and evidence-generation frameworks.
• Influence internal decision-making and external regulatory strategy through data-driven recommendations and leadership presence.

Who You Will Report To:

• VP Medical and Clinical Affairs

Qualifications:

• Advanced degree (Masters or PhD) inBiostatistics Statistics Epidemiology or a related quantitative field.
• 35 yearsof relevant experience in clinical research medical device pharmaceutical or regulated health technology sectors.
• Mastery of statistical software programming with extensive and proven experience with SAS. Other programs utilized could include R STATA Python.
• Experience supporting data management organization storage transfer and overall best practices.
• Understanding of clinical research designregulatory standards(e.g. ISO 14155 FDA guidance MDR/IVDR) and evidence-generation best practices.
• Demonstrated ability tocommunicate complex statistical concepts clearly both in writing and verbally.
• Experience contributing toscientific publications and/or conference presentationsis highly desirable.
• Strong attention to detail analytical mindset and ability to work both independently and collaboratively.
• Work location: Pleasanton based (hybrid)
• Travel: <10%
• Full-time employment

What Sets You Apart:

• A passion fortransforming data into strategic insightsthat drive innovation and patient impact.
• Asolution-focused mindsetwith a track record of anticipating challenges and proposing pragmatic high-quality solutions.
• Commitment to continuous improvement scientific rigor and excellence in execution

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:

• A competitive base salary of $165000 - $200000 and variable incentive plan
• Stock options ownership and a stake in growing a mission-driven company
• Employee benefits package that includes 401(k) healthcare insurance and paid vacation

Calyxo is deeply committed to fostering an environment where diversity and inclusion are not onlyvalued but alsoprioritized. 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 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:

• Structured Interview Process: Our hiring process includes multiple stages of interviews where you will have the opportunity to communicate directly with Calyxo employees. This ensures that you gain a comprehensive understanding of the role and our company culture.
• Verification of Identity: We do not extend job offers without first meeting candidates either virtually or in person. This step is crucial to maintain the integrity of our hiring process and to ensure mutual alignment.
• Beware of Scams: Calyxo will never request sensitive personal information such as your full name address phone number or identification documents via email or online forms before an official interview. Calyxo representatives will always contact you using an email format of. If you receive a request for information from any other domain please contact us directly at to verify the legitimacy of the communication.

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