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Siemens Healthineers Senior Director - Pre-Market Biostatistics (Remote) in Tarrytown, New York

Job Family: Research & Development

Req ID: 336342

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as Senior Director, Pre-Market Biostatistics, to lead biostatistics teams responsible for research and development of new products.

Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

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This is a role well suited to an ambitious professional, looking for the next step in their career. As a Senior Director, Pre-Market Biostatistics, you will be responsible for:

  1. Providing technical leadership, knowledge, and expertise in area of statistical analysis of clinical evaluations and analytical verification studies.

  2. Supervising biostatisticians responsible for end-to-end biostatistical support for analytical and clinical studies, inclusive of study plans, analyses, and reports preparation.

  3. Managing a diverse team consisting of permanent and contract employees. Developing individuals to their full technical potential. Providing input into the performance review and development plans of individuals within the framework of their current and future assignments.

  4. Contributing to budget planning, managing resource demand, and developing and improving departmental processes.

  5. Developing and applying statistical analysis strategies, in collaboration with internal and external partners responsible for evidence generation and verification protocols, to demonstrate value of key medical diagnostic products. Developing and innovating solutions to novel clinical science problems that utilize data obtained from controlled clinical trials and/or real-world data sources to verify and validate performance claims on new diagnostic assays.

  6. Working cross-functionally with internal and external partners to deliver scientifically and statistically valid evidence obtained from registrational and non-registrational studies.

  7. Serving as a subject matter expert in statistical analysis of analytical and clinical studies. Ensuring development of rigorous study designs and analysis plans, define clear and attainable statistical and scientific endpoints that demonstrate value locally and globally; determine best ways to present data to maximize interpretation and value to customers.

  8. Communicating updates to internal and external stakeholders; participating in internal and external meetings or forums.

Staying current with advances in statistical methods, applications, and regulatory requirements.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

• Supervising, coaching, mentoring, and developing technical teams.

• Networking and driving alignment cross-functionally to ensure statistically valid and robust studies intended to support product claims.

• Finding unique solutions to technical challenges in biostatistics and data management.

• Driving functional excellence in the areas of statistics, data analysis and data processing for department.

Required skills to have for the success of this role:

• Ph.D. or M.S. in Biostatistics with at least 15 years relevant experience. Prior experience in medical diagnostics is critical.

• Prefer at least 10 years of that experience be within medical diagnostic industry or biomarker research and development. At least 5 years of experience working in FDA regulated environments.

• Prefer at least 3 years of experience managing statistical teams responsible for product development and clinical studies intended to verify and validate intended product claims.

• Strong knowledge in areas of statistical analysis and programming, data management, and clinical and analytical study development

Experience supporting development of observational clinical research studies, including protocols, statistical analysis plans, and study reports

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

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If you want to join us in transforming the way healthcare is delivered, visit our career site at

If you wish to find out more about the specific before applying, please visit:

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Full / Part time: Full-time

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