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Position Overview
The Clinical Laboratory Biostatistician is a professional individual contributor who applies statistical methods to support clinical laboratory operations, assay development, validation, and quality control activities. This role uses established statistical principles, standard operating procedures, and regulatory guidelines to analyze laboratory data, support study design, and ensure product and process quality in compliance with CLIA, CAP, FDA, New York State, and other applicable regulatory requirements.
The role works collaboratively with laboratory, quality, and development teams and operates with moderate guidance, growing technical depth and business understanding while contributing to the day‑to‑day statistical needs of the clinical laboratory.
Essential Duties
Include, but are not limited to, the following:
- Perform routine and moderately complex statistical analyses on laboratory, validation, quality control, and clinical study data using established methods and tools.
- Support the development and execution of statistical analysis plans (SAPs) for laboratory studies, validations, and process monitoring activities.
- Analyze and trend laboratory data (e.g., QC metrics, process data) using prescribed methodologies, including basic statistical process control concepts.
- Translate scientific questions into appropriate established statistical approaches (or senior guidance) and clearly summarize results for technical and non‑technical audiences.
- Provide statistical support to laboratories, quality control, and development teams in areas such as:
- Design verification and validation
- Process transfer and ongoing monitoring
- Risk assessments and specification development
- Collaborate with peers and cross‑functional partners to complete assigned workstreams and deliverables on time.
- Conduct all work in compliance with the company Quality Management System (QMS), applicable SOPs, and regulatory requirements (CLIA, CAP, FDA, NYSDOH, etc.).
- Document statistical analyses and results in a clear, traceable, and inspection‑ready manner.
- Identify data trends or issues and escalate appropriately using defined processes.
- Communicate statistical concepts and justifications clearly in straightforward situations (written and verbal).
- Communicate statistical results in tables, listings, and figures and present results to cross-functional laboratory teams.
- Provide informal guidance or knowledge sharing to new team members or peers as requested.
- Continue to build knowledge of laboratory processes, business drivers, and statistical best practices.
- Participate in training related to statistics, laboratory operations, and quality systems.
- Regular and reliable attendance.
- Ability to work designated schedule.
- Ability to work nights and/or weekends as needed.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to work on a computer and phone simultaneously.
- Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
- Ability and means to travel between Madison locations.
Minimum Qualifications
- 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 for data analysis.
- Basic understanding of regulated laboratory environments and quality systems (CLIA, CAP, FDA, NYSDOH).
- Proficiency in Microsoft Excel (including pivot tables; macros preferred but not required).
- Strong verbal, written, and graphical communication/presentation skills.
- Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
- Master’s degree in Statistics, Biostatistics, or related field.
- Experience supporting clinical laboratory studies, validations, or quality control programs.
- Proficiency in SAS or R statistical programming.
- Proficiency in using 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.
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Salary Range:
$76,000.00 - $125,000.00
The annual base salary shown is for this position located in US - WI - Madison on a full-time basis. In addition, this position is bonus eligible.
Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage. Learn more about our benefits.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.
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