Job Description

Overview Senior Biostatistician role at Danaher Life Sciences (Radiometer). The position is part of Danahers Clinical Center of Excellence, will provide statistical support for clinical study design, analysis, and reporting for regulatory submissions (CE-IVD and US-IVD) of qualitative and quantitative IVD molecular assays across infectious disease, hematology, and oncology. The role will be the point of contact for regulatory questions pertaining to analysis. The position reports to the Senior Director, Biostatistics and is fully remote within the USA. In This Role, You Will Have The Opportunity To Provide end-to-end statistical analysis support for IVD product life cycle development, including creation and verification of multiplex biomarker signatures in infectious disease, blood diagnostics, and oncology for regulatory submission. Apply statistical methodologies such as general linear modeling, survival analysis, and multivariate classification tools as appropriate. Provide statistical input in clinical study designs, including sample size estimates and power considerations; communicate statistical risks of the design and sampling plan. Author statistical sections for clinical protocols, statistical analysis plans, statistical analysis reports, and clinical study reports submitted to FDA or other regulatory agencies. Review and update standard operating procedures; provide statistical training as needed; support audits of clinical data. Provide expert biostatistics input for analytical studies (reproducibility, precision studies, LOD, exclusivity/inclusivity, method comparisons, accuracy and linearity). The Essential Requirements Of The Job Include Bachelors Degree in Statistics or Biostatistics with 10+ years of experience OR MS in Statistics or Biostatistics with 10+ years of experience OR PhD in Statistics or Biostatistics with 5+ years of experience Experience as a lead statistician in analysis and reporting of IVD, medical devices, and imaging clinical studies in a regulated environment Knowledge of FDA, CE-IVDR, WHO and other diagnostics industry guidelines; ability to stay current on statistical standards (e.g., CLSI) and regulatory guidelines Proficiency with SAS, Excel, Minitab, Python or R; strong oral and written communication skills Ability to translate business, scientific, and engineering concepts into clear mathematical/statistical concepts understandable to non-statisticians It Would Be A Plus If You Also Possess Previous Experience In IVD regulatory submissions and regulatory interactions with FDA CDRH and CE Travel, Motor Vehicle Record & Environment Travel less than 5% Danaher offers a comprehensive benefits package and supports remote work for eligible roles. The annual salary range for this role is $114,700 - $157,700. This is a range in good faith and may be modified. The role may be eligible for bonus/incentive pay. We provide paid time off and medical/dental/vision insurance and 401(k) to eligible employees. Equal opportunity employer information and accommodation details are available upon request. We partner with customers globally to solve complex challenges, bringing the power of science to life. For more information, visit Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, or gender identity. If reasonable accommodation is needed to participate in the job application or interview process, contact 1-202-419-7762 or [email protected]. #J-18808-Ljbffr Danaher Life Sciences

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