Biostatistician – Clinical Trials; Drug​/Biologic

Biostatistician – Clinical Trials (Drug/Biologic)

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Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands‑on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!

Axogen is an equal‑opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.

• Friendly, open, and fun team culture that values unique perspectives
• Company‑wide dedication to profoundly impacting patients’ lives
• Comprehensive, high‑quality benefits package effective on date of hire
• Educational assistance available for all employees
• Matching 401(k) retirement plan
• Paid holidays, including floating holidays, to be used at your discretion
• Employee Stock Purchase Plan
• Referral incentive program

Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit‑to‑risk profile as compared to existing standards of care. To ensure we deliver improved benefit‑to‑risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.

The Biostatistician is responsible for the design and conduct of clinical research studies, including developing statistical analysis plans, performing basic and complex statistical analysis, interpreting and reporting study results, and other required activities as needed. Responsibilities include providing data analysis input to meet project objectives, contributing to statistical analysis sections of IRB and grant applications, developing and executing statistical programs, drafting analysis and results sections of clinical study reports and scientific papers, and supporting general publication of study findings.

• A Ph.D. degree or equivalent in statistical science, mathematical analysis or related field plus 5 years’ relevant experience, or a master’s degree plus 8 years’ relevant experience with demonstrated ability and sustained performance at the Ph.D. level.
• Minimum 5 years of experience working in the biologic/biotechnology, pharmaceutical, and/or medical device industry.
• Demonstrated success in delivering on goals and being part of fast‑moving, collaborative team.
• Broad regulatory understanding of functions and processes involved in pharmaceutical, biologic, and/or medical device product development.
• Strong interpersonal, written, and oral communication skills across various levels of management and ability to manage differences and needs between multiple stakeholders.

• Leadership and Project Management:
  • Lead efforts in resolving day‑to‑day work related issues and problems, securing quality, improving efficiency and productivity of statistical and programming operations.
  • Apply project management skills, statistical and programming techniques, and achieve quality and on‑time delivery of deliverables.
  • Coordinate activities with project/program overall management personnel to achieve program objectives.
  • Under supervision may represent the company to interact with regulatory agencies regarding matters relating to the statistical areas of the responsible projects/programs.
• Statistical Planning and Methodologies:
  • Provide strong statistical expertise for design, analysis and reporting of clinical trials and research projects.
  • Write statistical sections of study protocols, perform sample size calculation, develop randomization specifications, and generate randomization codes.
  • Write Statistical Analysis Plans (SAPs) and properly…