We are seeking a highly skilled Principal Biostatistician to join our team in the development of cutting-edge medical diagnostics. As a key member of our biostatistics team, you will be responsible for developing and applying innovative statistical analysis and analytics strategies to support product development and clinical validation of new medical diagnostics.

• Develop and apply statistical analysis and analytics strategies to support product development and clinical validation of new medical diagnostics.
• Collaborate with internal and external partners to deliver scientifically and statistically valid evidence obtained from registrational and non-registrational studies.
• Serve as a subject matter expert in statistical analysis of analytical and clinical trials.
• Ensure development of rigorous study designs and analysis plans, define clear and attainable statistical and scientific endpoints that demonstrate value locally and globally.
• Communicate findings to internal and external partners, regulatory and scientific communities; prepare manuscripts and publications; participate in internal and external meetings or forums to present insights.
• Contribute to external engagements with collaborators, consultants, thought leaders, advisory boards, congresses, and scientific meetings.
• Stay current with advances in statistical methods, applications, and regulatory requirements.

• Ph.D. in Statistics with at least 10 years relevant experience.
• Prefer at least 6 years of that experience be within medical diagnostic industry or biomarker research and development.
• Experience with FDA submission processes (510k, PMA, EUA) is preferred.
• Strong knowledge and experience with clinical trial designs, statistical analysis methods and theory, clinical and laboratory data management systems (eDC, LIMS) and statistical programming (R preferred).
• Can effectively apply innovative statistical solutions to scientific and business problem solving.
• Excellent interpersonal skills (oral and written communication, influence, collaboration, presentation).
• Must be fluent in English.
• Candidate must be able to work legally in the United States. No sponsorship is available.

We are a team of more than 71,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.