Job Description
Job Description
Looking for a Statistician/Biostatistician to support analytical and clinical studies for diagnostic products. This role focuses on writing statistical analysis plans, analyzing clinical and validation data, and supporting regulatory submissions. You will use SAS to run analyses, create tables and figures, and ensure accuracy and quality of statistical outputs.
• Write and review statistical analysis plans for analytical and clinical validation studies.
• Apply DOE principles, conduct statistical analyses, and clearly communicate interpretations.
• Calculate clinical accuracy metrics (PPA, NPA, PPV, NPV) and deliver analyses to support regulatory filings.
• Generate tables, listings, and figures aligned with study protocols.
• Review and QC statistical outputs from peers, ensuring scientific integrity.
• Write and validate SAS code and macros to support standardized workflows.
• Collaborate in cross-functional study teams, contributing data...
Looking for a Statistician/Biostatistician to support analytical and clinical studies for diagnostic products. This role focuses on writing statistical analysis plans, analyzing clinical and validation data, and supporting regulatory submissions. You will use SAS to run analyses, create tables and figures, and ensure accuracy and quality of statistical outputs.
• Write and review statistical analysis plans for analytical and clinical validation studies.
• Apply DOE principles, conduct statistical analyses, and clearly communicate interpretations.
• Calculate clinical accuracy metrics (PPA, NPA, PPV, NPV) and deliver analyses to support regulatory filings.
• Generate tables, listings, and figures aligned with study protocols.
• Review and QC statistical outputs from peers, ensuring scientific integrity.
• Write and validate SAS code and macros to support standardized workflows.
• Collaborate in cross-functional study teams, contributing data...