Senior Biostatistician - R&D (Remote)

• Location: Madison, Wisconsin
• Remote: Remote
• Type: Contract
• Job #3978

Our Partner is hiring a Senior Statistician within their R&D division.  This role provides leadership and direction to the Commercial Lab and to product development activities, ensuring product and process conformance to FDA and ISO standards. This role will provide support to Research, Product Development, Commercial Lab, Clinical Operations, and System Development teams for a variety of functions, including analysis of large datasets, fitting models to biological data, clinical study data quality control, data trend analysis, and statistical process control.

What you’ll do:

• Provide subject matter expertise in statistical process monitoring, troubleshooting where atypical data is observed, and interacting with Commercial Lab personnel regarding status and development of process monitoring methodology.
• Perform data quality control of clinical and/or R&D study data.
• Provide statistical support for study designs including calculating sample size requirements, recommending data analysis methods, performing statistical analysis of study data, and report authoring.
• Represent Non-Clinical Biostatistics (NCB) in interdepartmental meetings.
• Engage with new product development teams and provide expert consultation in the areas of design control, design verification and validation, design transfer, process transfer, risk management, and specification development.
• Engage in and lend expertise to product development and product or process improvement projects and participate in product lifecycle phase reviews.
• Develop statistical analysis to support Commercial and R&D initiatives.
• Effectively communicate, collaborate, and interface with programmers and research scientists, Clinical Affairs, and Regulatory Affairs personnel.
• Ability to translate scientific hypotheses into statistical models and interpret results of those models.
• Ability to lead and work effectively with and through multi-functional teams to achieve results.
• Excellent interpersonal skills with the ability to collaborate closely with Development and Clinical Operations staff at varying levels to drive compliance and operational excellence.
• Excellent problem-solving skills and ability to correlate statistical findings with potential process improvement opportunities.
• Ability to plan and interpret results for Design of Experiments (DOE).

What you’ll bring:

• Master’s degree in Statistics, Mathematics, Physics, Computer Science, Computational Biology, Epidemiology, Biostatistics, or related computational discipline.
• Minimum of 8 years of relevant experience.  Relevant experience includes, but is not limited to, fitting models to biological data and experience planning and interpreting results for DOE.
• Demonstrated ability to correlate statistical findings with potential process improvement opportunities.
• Strong fundamental understanding of probability, significance, and dealing with uncertainty and measurement error in large datasets.
• Demonstrated ability using Statistical Process Control (SPC).
• Demonstrated ability fitting models to biological data.
• Demonstrated ability with statistical software that may include but not be limited to JMP, SAS, R, Python.

• Five (5) or more years of experience in a Good Manufacturing Practice (GMP) and/or ISO13485 development environment.
• Knowledge of FDA guidelines for analytical performance studies and clinical validation.
• Experience in the areas of design control, design verification and validation, design transfer, process transfer, risk management.
• Proficiency with Tableau software.