Senior Biostatistician

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. • Review study protocols, Case Report Forms (CRFs), and study documentation to ensure data are collected appropriately to support study objectives and regulatory 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. Furthermore, information will only be released internally on a need-to-know basis. All Team Members will not discuss patient cases outside the office or with anyone not employed by this company unless they are directly involved with the patient’s case. COMPETENCIES • Passion: Contagious excitement about the company – sense of urgency. Commitment to continuous improvement. • Integrity: Commitment, accountability, and dedication to the highest ethical standards. • Collaboration/Teamwork: Inclusion of Team Member regardless of geography, position, and product or service. • Action/Results: High energy, decisive planning, timely execution. • Innovation: Generation of new ideas from original thinking. • Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind. • Emotional Intelligence: Recognizes, understands, manages one’s own emotions and is able to influence others. A critical skill for pressure situations. • Strong scientific and statistical reasoning with a commitment to data integrity and quality. • Ability to independently lead complex projects and drive deliverables to completion. • Demonstrated expertise in clinical trial design, epidemiology, and real-world evidence methodologies. • Strong problem-solving, critical thinking, and decision-making skills. • Excellent written, verbal, and presentation skills with the ability to communicate complex analyses to technical and non-technical audiences. • Collaborative team player with the ability to influence across functions. • Adaptability and effectiveness in a fast-paced, growth-oriented environment. • Commitment to continuous learning and implementation of emerging statistical methodologies and industry best practices. • Proficiency with statistical, database, and visualization tools including SAS, R, Python, SQL, Excel, Power BI, and PowerPoint. QUALIFICATIONS Education/Experience Required: • Master's degree or PhD in Biostatistics, Statistics,