Tarrytown, New York
20 days ago
Senior Director of Biostatistics



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Apply now for the position of Senior Director of Clinical Biostatistics, and you will lead biostatistics teams responsible for research and development of cutting-edge immunodiagnostics. This role will report to the Vice President of Biostatistics, Analytics, and Data Management within Medical Affairs.

Your role:

Providing technical leadership, knowledge, and expertise in area of statistical analysis of clinical evaluations and analytical verification studies for immunodiagnostic devices.Supervising biostatisticians responsible for end-to-end biostatistical support for analytical and clinical studies, inclusive of study plans, analyses, and reports preparation. 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.Contributing to budget planning, managing resource demand, and developing and improving departmental processes.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 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.

Your expertise:


Master of Science degree or higher in Biostatistics, Mathematics, or Statistics.  Minimum of 15 years of experience in supporting study design and statistical analysis of studies to validate analytical and clinical performance of immunodiagnostics is required.Prefer at least 3 years of experience managing statistical teams or special statistical consulting projects aimed at verifying and validating intended product claims of immunodiagnostic devices in one or more of the following diagnostic application areas: infectious disease, cardiovascular disease, liver disease, oncology, neurology, women’s health. Broad experience with providing statistical consulting on studies submitted through with various FDA regulatory pathways: assay migration and reagent replacement, 510k, PMA, and Emergency Use Authorization regulatory pathways.Strong knowledge of statistical theory and methods, SAS or R statistical programming language, and best programming practices..

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The pay range for this position is $225,000 - $250,000 U.S. dollars annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience, as well as where the work will be performed. The annual incentive target is (25%) 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  

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