The Kestra team has over 400 years of experience in the external and internal cardiac medical device markets. The company was founded in 2014 by industry leaders inspired by the opportunity to unite modern wearable technologies with proven device therapies. Kestra’s solutions combine high quality and technical performance with a wearable design that provides the greatest regard for patient comfort and dignity.

Innovating versatile new ways to deliver care, Kestra is helping patients and their care teams harmoniously monitor, manage, and protect life. The Senior Biostatistician is responsible for providing statistical leadership across the clinical research lifecycle, including study design, protocol development, data analysis, reporting, publications, and regulatory submissions. This role ensures that rigorous statistical methodologies are applied to generate high-quality clinical evidence supporting Kestra products.

ESSENTIAL DUTIES: Clinical Study Design and Statistical Leadership • Provide statistical leadership for the design, conduct, analysis, and reporting of clinical research studies, including observational studies, randomized controlled trials, registries, and real-world evidence (RWE) studies. • Collaborate with clinical, regulatory, medical, and engineering teams to develop scientifically rigorous and operationally feasible study designs. • Perform sample size calculations, power analyses, endpoint selection, and statistical methodology development.

• Author and maintain Statistical Analysis Plans (SAPs), including study objectives, hypotheses, analysis populations, endpoints, and statistical methods.

Requirements

• Apply sound epidemiologic and biostatistical principles while balancing scientific rigor, operational constraints, timelines, and ethical considerations. Data Analysis and Statistical Programming • Develop, validate, and execute statistical programs using SAS, R, Python, SQL, or other appropriate tools. • Create and maintain analysis datasets, tables, listings, figures, and statistical outputs for clinical studies and regulatory submissions.

• Perform exploratory, descriptive, inferential, and advanced statistical analyses, including survival analyses, regression modeling, and longitudinal data analyses. • Conduct quality control, code review, and validation procedures to ensure data integrity, reproducibility, and compliance with internal standards. • Integrate and analyze data from multiple sources, including clinical trial databases, registries, electronic health records, and claims databases.

• Identify data anomalies, outliers and trends and partner with study teams to resolve data quality issues. Reporting, Publications, and Regulatory Support • Author statistical sections of clinical study reports, regulatory submissions, scientific manuscripts, abstracts, posters, and presentations. • Translate complex statistical findings into clear and actionable conclusions for clinical, regulatory, executive, and commercial audiences.

• Prepare and present study results to investigators, management, regulatory agencies, advisory boards, and external stakeholders. • Support regulatory interactions and provide statistical expertise for submissions, audits, and agency communications. Cross-Functional Collaboration • Partner closely with Clinical Research Specialists, Regulatory Affairs, Quality, Engineering, IT, and external collaborators.

• Ensure compliance with applicable SOPs, FDA regulations, GCP, ICH guidelines, and industry best practices. • Serve as lead statistician on assigned projects and manage multiple priorities with minimal supervision. Adhere to Pledge of Confidentiality Information regarding a patient of this company shall not be released to any source outside of this company without the signed permission of the patient.