Senior Biostatistician- Biotech

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.

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.

Partner closely with Clinical Research Specialists, Regulatory Affairs, Quality, Engineering, IT, and external collaborators.

• Serve as lead statistician on assigned projects and manage multiple priorities with minimal supervision.

outside the office or with anyone not employed by this company unless they are directly involved

Commitment to continuous improvement.

• Inclusion of Team Member regardless of geography, position, and product or service.
• High energy, decisive planning, timely execution.
• Innovation: Customer Focus: Exceed customer expectations, quality of products, services, and experience always present of mind.
• Emotional Intelligence: 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.
• Excellent written, verbal, and presentation skills with the ability to communicate complex analyses to technical and non-technical audiences.
• 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.

Master's degree or PhD in Biostatistics, Statistics, Epidemiology, or related quantitative discipline.

• Minimum 5 years of experience supporting clinical research, clinical 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, ICH guidelines, and clinical research standards.
• Ability to effectively collaborate with physicians, clinical researchers, regulatory professionals, data managers, engineers, and software teams.

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., Experience supporting FDA submissions, post-approval studies, and international regulatory requirements.
• Prior experience serving as lead statistician for multicenter clinical studies and publication programs.

WORK ENVIRONMETNT • Indoor open office environment

• Minimal noise volume typical to an office environment
• Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug

Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a

Frequent computer use

• Frequent phone and other business machine use

• TRAVEL

• Occasional travel, domestic and international, may be required, less than 10%

Kestra offers a very competitive benefit package including Medical, Dental, 401K with Match, etc.

Pay equity is an important part of Kestra's Culture. Our compensation ranges are guided by national and local salary surveys and take into consideration experience level and internal equity. Annualized at $140,000 - $160,000 plus bonus. Kestra Medical Technologies is an equal opportunity employer. Kestra Medical Technologies does not discriminate on the basis of race, color, religion, national origin, veteran status, age, sexual orientation, gender identity and/or expression, marital status, disability, physical or mental status or any other characteristic protected by law.

We are unable to sponsor or take over sponsorship of visas (any) at this time. Kestra manufactures and provides life-saving products regulated by the Federal Food and Drug Administration and under contract with Medicare. Kestra maintains a drug free workplace and testing is a condition of employment.

Kestra Medical Technologies, Inc does not discriminate on the basis of race, sex, color, religion, age, national origin, marital status, disability, veteran status, genetic information, sexual orientation, gender identity or any other reason prohibited by law in provision of employment opportunities and benefits.