Biostatistician - Pleasanton, CA at Calyxo

Pleasanton, California, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Feb, 26

Salary

200000.0

Posted On

10 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Biostatistics, Statistical Analysis, Clinical Research, Regulatory Compliance, Data Visualization, Statistical Software, SAS, R, Epidemiology, Evidence Generation, Study Design, Real-World Evidence, Cross-Functional Collaboration, Scientific Communication, Attention to Detail, Analytical Mindset

Industry

Medical Equipment Manufacturing

Description

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 Serve as the statistical lead for 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 with GCP, ISO 14155, ICH E9/E10, and other applicable standards while staying current with evolving regulatory trends and expectations. Scientific Communication Collaborate on the development of scientific publications, abstracts, posters, and presentations based on clinical study data. Assist in creating clear, compelling data visualizations and summaries for both internal and external stakeholders. Post-Market & Real-World Evidence (RWE) Leadership Support the analysis of real-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 to evidence 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 clear, actionable insights for diverse technical and non-technical audiences. Provide strategic input on 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 (Master’s or PhD) in Biostatistics, Statistics, Epidemiology, or a related quantitative field. 3–5 years of 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 design, regulatory standards (e.g., ISO 14155, FDA guidance, MDR/IVDR), and evidence-generation best practices. Demonstrated ability to communicate complex statistical concepts clearly, both in writing and verbally. Experience contributing to scientific publications and/or conference presentations is highly desirable. Strong attention to detail, analytical mindset, and ability to work both independently and collaboratively. Work location: Pleasanton based (hybrid) Travel:

Responsibilities

Lead the statistical strategy, analysis, and interpretation of data across the medical device product lifecycle. Serve as the statistical lead for global regulatory submissions and ensure compliance with applicable standards.