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, 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.

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

SUPERVISORY RESPONSIBILITIES

None

WORK ENVIRONMETNT

Indoor open office environment Minimal noise volume typical to an office environment Extended hours when needed 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 post-offer.

PHYSICAL DEMANDS

Frequent repetitive motions that may include wrists, hands and/or fingers, such as keyboard and mouse usage Frequent stationary position, often standing or sitting for prolonged periods of time Frequent computer use Frequent phone and other business machine use Occasional lifting required, up to 20 pounds TRAVEL Occasional travel, domestic and international, may be required, less than 10%

OTHER DUTIES

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the Team Member. Duties, responsibilities, and activities may change or new ones may be assigned at any time with or without notice.

BENEFITS

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. Each role is benchmarked based on the job description provided If your qualifications and/or experience level are outside of the posted position, we encourage you to apply as we are growing fast and roles that are coming soon may not be posted.

Salary:

Annualized at $140,000 - $160,000 plus bonus. Depending on experience. 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. Applicants must be eligible to work for any employer in the U.S. 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. 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