Senior Biostatistician

Kestra is a medical device company founded in 2014 that combines wearable technologies with proven device therapies to provide patient-friendly solutions. This role focuses on statistical leadership throughout the clinical research lifecycle, ensuring rigorous and high‑quality evidence to support Kestra products.

• 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 studies.
• Collaborate with clinical, regulatory, medical, and engineering teams to develop statistically sound and operationally feasible study designs.
• Perform sample size calculations, power analyses, endpoint selection, and develop statistical methodologies.
• Author and maintain Statistical Analysis Plans (SAPs) covering objectives, hypotheses, analysis populations, endpoints, and statistical methods.
• Review study protocols, CRFs, and documentation to ensure data collection supports study objectives and regulatory requirements.
• Apply epidemiologic and biostatistical principles while balancing scientific rigor, operational constraints, timelines, and ethical considerations.

• 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 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 such as 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.

• 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.

• 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.

Education/Experience

Required:

• Master’s degree or PhD in Biostatistics, Statistics, Epidemiology, or related quantitative discipline.
• Minimum five (5) years of experience supporting clinical research, trials, registries, or real‑world evidence studies in the medical device, biotechnology, pharmaceutical, or healthcare industry.
• Demonstrated experience in clinical study design, statistical analysis, and interpretation of clinical data.
• Proficiency with statistical programming tools, including SAS and/or R.
• Experience with SQL and relational database structures.
• Strong knowledge of survival analysis, regression methods, longitudinal data analysis, and observational study methodologies.
• Experience supporting scientific publications and regulatory submissions.
• Working knowledge of FDA regulations, GCP, and ICH guidelines.
• Ability to collaborate effectively with physicians, clinical researchers, regulatory professionals, data managers, engineers, and software teams.

Preferred:

• Experience with medical device clinical development and post‑market studies.
• Experience working with healthcare claims, EHR, registry, and other real‑world data sources (e.g., Optum, Health…