Senior Statistician II, R&D

Summary of Major Responsibilities:
The Senior Statistician II, R provides leadership and direction to Commercial Lab Redwood City support 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.

Essential Duties and Responsibilities:
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 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 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).Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Ability to act with an inclusion mindset and model these behaviors for the organization.Support and comply with the company's Quality Management System policies and procedures. Regular and reliable attendance. Ability to work nights and/or weekends on an ad hoc basis.Ability to frequently and accurately communicate with employees in person, via telephone or by email.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.

Qualifications:
Minimum QualificationsMaster'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.Proficiency in Microsoft Office to include Excel, Word, and PowerPoint.Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred QualificationsFive (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.

EEO Disclosure:
We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. Applicable portions of the Company's affirmative action program are available to any applicant or employee for inspection upon request.