Senior Staff Biostatistician-Pre-Market Biostatistics-Remote

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 Sr Staff Biochemist within Pre-Market Biostatistics.

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. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers.

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Sr Staff Biochemist, you will be responsible for:

• 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. 
• Working cross-functionally with internal and external partners to deliver scientifically and statistically valid evidence obtained from registrational and non-registrational studies.
• Serving as a subject matter expert on product development teams 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 
• 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
• Strong knowledge of statistical theory, experimental design and clinical trial methodologies, linear and nonlinear modeling, categorical and non-parametric methods, survival analysis, and associated sample size calculations. Familiarity with diagnostic clinical trial statistics is required.
• Proficiency in statistical programming (SAS, R) and query of relational database systems (SQL). Certifications in SAS programming a plus.
• Experience with extraction of data and reporting within Clinical Data Management systems (e.g., Medidata RAVE, Medrio, Oracle Clinical).
• Ability to understand scientific questions and formulate statistical and data-analytic methods to provide solution to novel problems.
• Familiar with FDA guidelines and CLSI guidelines applicable to medical diagnostics is required. 
• Experience with analysis of complex data from multiple sources. 
• Ability to work independently and in project teams. Highly motivated and driven to exceed expectations.
• Strong communication skills in English, written and spoken. Strong ability for public speaking in audiences with mixed backgrounds. Able to distill complex statistical concepts in simpler terms to generalized audiences

Required skills to have for the success of this role

• Masters degree or Ph. D. in Statistics or Biostatistics. Exceptional candidates with other STEM degrees bridging biological science, will be considered.
• At least 10 years’ experience supporting analytical and clinical verification and validation studies within the in vitro diagnostics industry.
• Strong knowledge and demonstrated experience in statistical modeling and simulation, clinical trial study design, statistical programming (SAS), and data wrangling.
• Demonstrated progressive responsibility and statistical expertise to support analytical and clinical verification studies from planning through regulatory submission

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.

The pay range for this position is $$XXX - $$XXX annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is (15%) of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html

This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

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 https://usa.healthcare.siemens.com/careers. 

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about. 

“Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”