• Contribute to and shape the design of MRD-focused studies, including clinical validity studies, registries, and real-world evidence programs, defining endpoints, analysis strategies, and overall statistical approach across multiple concurrent programs 
• Perform sample size and power calculations, support endpoint justification, and draft statistical sections of study protocols 
• Independently perform statistical analyses across diverse datasets (clinical, assay/validation, and real-world/registry data) using appropriate methods (e.g., regression, survival analysis, validation approaches), ensuring accuracy, reproducibility, and appropriate documentation 
• Serve as the statistical point of contact for assigned studies; partner with clinical, translational, and data teams, as well as external collaborators, to support study execution and communicate statistical concepts, methods, and results clearly to non-statistical stakeholders 
• Identify study risks and provide data-driven recommendations to support study integrity and decision-making 
• Develop, manage, and maintain statistical deliverables (analysis summaries, tables/listings/figures, study reports) and lead or contribute to the development of Statistical Analysis Plans (SAPs) 
• Contribute to abstracts, manuscripts, and scientific presentations supporting evidence generation and publication strategy 
• Manage statistical deliverables across multiple concurrent studies, ensuring timelines, quality, and consistency of outputs 
• Lead or contribute to development of statistical templates, tools, and workflows, while building subject matter expertise in MRD and oncology study methodologies 

Minimum Requirements:

• MS in Biostatistics, Statistics, or a related quantitative field 
• 6 or more years of experience in clinical biostatistics within biotechnology, diagnostics, CRO, or related healthcare environments 
• 5 or more years of experience in statistical programming (R, SAS or equivalent acceptable) 
• 3 or more years of experience supporting clinical research studies, including observational studies, registries, and/or assay validation efforts 
• 3 or more years of experience independently managing statistical analyses and deliverables across multiple concurrent studies 

Preferred Requirements: