Clinical Laboratory Biostatistician

Responsibilities

• Perform routine and complex statistical analyses on laboratory, validation, quality control, and clinical study data.
• Support the development and execution of statistical analysis plans (SAPs) for laboratory studies and process monitoring.
• Analyze and trend laboratory data using prescribed methodologies, including statistical process control concepts.
• Translate scientific questions into appropriate statistical approaches and summarize results for technical and non-technical audiences.
• Provide statistical support for design verification, validation, process transfer, and risk assessments.
• Document all statistical analyses and results in a clear, traceable, and inspection-ready manner in compliance with QMS and regulatory requirements.
• Collaborate with cross-functional laboratory, quality, and development teams to complete deliverables.

Requirements

• Bachelor’s degree in Statistics, Biostatistics, Mathematics, Life Sciences, or a related field.
• 3 years of relevant experience applying statistical methods to laboratory, clinical, or regulated data sets.
• Working knowledge of probability, significance/hypothesis testing, linear regression, and data variability.
• Experience using statistical software such as R, JMP, SAS, or Python.
• Basic understanding of regulated laboratory environments and quality systems (CLIA, CAP, FDA, NYSDOH).
• Proficiency in Microsoft Excel, including pivot tables.
• Strong verbal, written, and graphical communication and presentation skills.

Preferred Qualifications

• Master’s degree in Statistics, Biostatistics, or a related field.
• Experience supporting clinical laboratory studies, validations, or quality control programs.
• Advanced proficiency in SAS, R, or JMP for statistical analysis and data visualization.
• Familiarity with basic SPC concepts and trend analysis in a laboratory setting.
• Experience working cross-functionally within a regulated healthcare or diagnostics organization.

Benefits

• Paid time off including vacation, holidays, volunteering, and personal time.
• Paid leave for parents and caregivers.
• Retirement savings plan.
• Comprehensive wellness support.
• Health benefits including medical, prescription drug, dental, and vision coverage.

About the Company

Exact Sciences is helping change how the world prevents, detects, and guides treatment for cancer. We provide patients and clinicians with the clarity needed to make confident decisions when they matter most.