|Date Posted||January 19, 2021|
|Address||441 Charmany Drive|
Summary of Major Responsibilities
The Clinical Laboratory Biostatistician provides leadership and direction to clinical laboratory development activities, ensuring product and process conformance with Quality Management program, and in compliance with all laws and regulations required by CLIA, CAP, OSHA, New York, and any other applicable state or federal legislative organizations.
This role will provide support to Technical Laboratory, Specimen Processing, Clinical Development, Systems Development, and Service and Support teams for a variety of functions including analysis of large datasets, fitting models to biological data, clinical study modeling, data trend analysis, and statistical process control.
Essential Duties and Responsibilities
- Perform statistical activities in collaboration across the clinical laboratory, including protocol and analysis plan development, data analysis, and preparation of final study reports and technical summaries, with minimal supervision.
- Provide statistical input to Laboratory teams in the areas of design control, design verification and validation, design transfer, process transfer, risk management, and specification development.
- Provide statistical support for study designs; including sample size requirements, recommend data analysis methods, and perform statistical analysis of study data.
- Support the development and review of statistical analysis plans for clinical studies, validations, trials, and quality control analysis.
- Support continuous improvement efforts in the design control and design transfer processes, production, and standard operating procedures (SOPs) relating to the product development process.
- Support product risk management activities; including system hazard analyses and product risk assessments.
- Communicate, collaborate, and interface effectively with laboratory team members and technical scientists, quality control teams, and clinical development personnel.
- Provide training to all levels of personnel on the use and interpretation of statistics.
- Ability to translate scientific hypotheses into statistical models and interpret results of those models.
- Ability to work effectively with and through multi-functional teams to achieve results.
- Ability to collaborate closely with development staff at varying levels to drive compliance and operational excellence.
- Ability to utilize problem solving skills and correlate statistical findings with potential process improvement opportunities.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work designated schedule.
- Ability to work nights and/or weekends.
- 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.
- Bachelor’s degree in statistics, biostatistics, mathematics, life sciences, or field related to the essential duties of the position.
- 4+ years of relevant experience in statistics, mathematics, physics, computer science, computational biology, biostatistics, or related computational discipline.
- 2+ years of experience applying computational techniques to large biological datasets.
- Strong fundamental understanding of probability, significance, and dealing with uncertainty and measurement error in large datasets.
- Basic working knowledge of laws and regulations required by FDA, CLIA, CAP, OSHA, New York, and any other applicable state or federal legislative organizations.
- Proficiency in techniques such as Maximum likelihood estimation, Bayesian inference, particle filtering, Linear regression, Generalized Linear Models, unsupervised learning algorithms, significance/hypotheses testing, sensitivity analysis etc.
- Proficiency in using statistical software for analysis such as SAS, R, JMP, or Python.
- Proficient in Microsoft Office to include Excel macros and pivot tables.
- Authorization to work in the United States without sponsorship.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
- Master’s degree in statistics, biostatistics, mathematics, life sciences, or related discipline.
- 2+ years of experience in a Clinical Laboratory environment.
- Basic understanding of CAP/CLIA and New York guidelines for analytical performance studies and clinical validation.