Radiometer
Overview
Senior Biostatistician role within Danaher’s Clinical Center of Excellence, fully remote in the USA. Provides statistical support for clinical study design, analysis, and reporting for registration/pre-market approval of qualitative and quantitative IVD molecular assays in infectious disease, hematology, and oncology across Danaher Diagnostics operating companies. Serves as the point of contact for regulatory questions pertaining to analysis. Pay
Base pay range: $114,700.00/yr - $157,700.00/yr. The annual salary range stated is the range the company believes is the range of possible compensation at the time of posting and may be modified in the future. This role is eligible for a bonus/incentive pay. Responsibilities
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 (general linear modeling, survival analysis, multivariate classification tools, etc.). Provide statistical input in clinical study designs, including sample size estimates using OC and power curves, and communicate statistical risks of the study design and sampling plan to the team. 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 for relevant functions, provide statistical training/education to other teams as needed, and support audits of clinical data. Provide expert biostatistics input for analytical studies such as reproducibility and precision studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity studies. Essential requirements
Bachelor’s 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 trends in the IVD industry and regulatory guidelines. Experience with SAS, Excel, Minitab, Python or R, with strong oral and written communication skills. Ability to translate business, scientific, and engineering concepts into clear mathematical/statistical concepts and communicate them to non-statisticians. Nice to have
Experience with IVD regulatory submissions and regulatory interactions with FDA CDRH and CE. Travel & Environment
Travel less than 5%. Benefits and work arrangement
Radiometer, a Danaher operating company, offers comprehensive benefits including health insurance and 401(k). The position is eligible for remote work from home. Details will be provided by the interview team. Equal opportunity
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, gender identity, or other characteristics protected by law. U.S. EEO posters are available, and reasonable accommodations are provided for applicants and employees with disabilities. If accommodation is needed to participate in the application or interview process, to perform essential job functions, or to receive benefits, please contact: 1-202-419-7762 or applyassistance@danaher.com.
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Senior Biostatistician role within Danaher’s Clinical Center of Excellence, fully remote in the USA. Provides statistical support for clinical study design, analysis, and reporting for registration/pre-market approval of qualitative and quantitative IVD molecular assays in infectious disease, hematology, and oncology across Danaher Diagnostics operating companies. Serves as the point of contact for regulatory questions pertaining to analysis. Pay
Base pay range: $114,700.00/yr - $157,700.00/yr. The annual salary range stated is the range the company believes is the range of possible compensation at the time of posting and may be modified in the future. This role is eligible for a bonus/incentive pay. Responsibilities
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 (general linear modeling, survival analysis, multivariate classification tools, etc.). Provide statistical input in clinical study designs, including sample size estimates using OC and power curves, and communicate statistical risks of the study design and sampling plan to the team. 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 for relevant functions, provide statistical training/education to other teams as needed, and support audits of clinical data. Provide expert biostatistics input for analytical studies such as reproducibility and precision studies, interfering substances, limit of detection (LOD), exclusivity and inclusivity studies, method comparisons, accuracy, and linearity studies. Essential requirements
Bachelor’s 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 trends in the IVD industry and regulatory guidelines. Experience with SAS, Excel, Minitab, Python or R, with strong oral and written communication skills. Ability to translate business, scientific, and engineering concepts into clear mathematical/statistical concepts and communicate them to non-statisticians. Nice to have
Experience with IVD regulatory submissions and regulatory interactions with FDA CDRH and CE. Travel & Environment
Travel less than 5%. Benefits and work arrangement
Radiometer, a Danaher operating company, offers comprehensive benefits including health insurance and 401(k). The position is eligible for remote work from home. Details will be provided by the interview team. Equal opportunity
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, gender identity, or other characteristics protected by law. U.S. EEO posters are available, and reasonable accommodations are provided for applicants and employees with disabilities. If accommodation is needed to participate in the application or interview process, to perform essential job functions, or to receive benefits, please contact: 1-202-419-7762 or applyassistance@danaher.com.
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