|at ( view profile)|
|Date Posted||March 29, 2019|
|Address||441 Charmany Dr|
Summary of Major Responsibilities
The Senior Statistician, provides leadership and direction to product development activities, ensuring product and process conformance. This role will provide support 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.
For this opportunity, the Senior Statistician will support the Research and Development and System Development teams. This role will be responsible for ensuring product and process conformation to FDA and ISO standards.
Essential Duties and Responsibilities
- Provide leadership and statistical input to new product development teams in the areas of design control, design verification and validation, design transfer, process transfer, risk management, and specification development.
- Provide guidance in the analysis and interpretation of clinical/experimental study data.
- Provide leadership on product development and product or process improvement projects, and participate in product life cycle phase reviews.
- Develop statistical analysis to support business functions' initiatives.
- Provide statistical support for study designs including sample size requirements, recommend data analysis methods and perform statistical analysis of study data.
- Development and review of statistical analysis plans for clinical trials.
- Support continuous improvement efforts in the design control and design transfer processes, production, and standard operating procedures relating to the product development process.
- Support product risk management activities including system hazard analyses and product risk assessments.
- 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.
- Provide training to all levels of personnel on the use and interpretation of statistics.
- Perform other related duties as assigned by management.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work nights and/or weekends.
- Ability to work seated for approximately 90% of a typical working day. Ability to work standing for approximately 10% of a typical working day.
- Ability to work in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
- Ability to frequently and accurately communicate with employees in person, via the telephone or by email.
- Proven 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 staff at varying levels to drive compliance and operational excellence.
- Knowledge and experience working within an CFR 820, ISO 13485, ISO 12207 and/or cGMP structured environment.
- Ph.D. in statistics, mathematics, physics, computer science, computational biology, epidemiology, biostatistics, or related computational discipline; or Master’s in statistics, mathematics, physics, computer science, computational biology, epidemiology, biostatistics, or related computational discipline with a minimum of 4+ years of relevant experience in lieu of Ph.D..
- 4+ years of relevant experience in statistics, mathematics, physics, computer science, computational biology, epidemiology, biostatistics, or related computational discipline.
- Experience applying computational techniques to large biological datasets.
- Experience fitting models to biological data is preferred.
- Strong fundamental understanding of probability, significance, and dealing with uncertainty and measurement error in large datasets.
- Experience with clustering algorithms, differential equation models, and machine learning algorithms.
- 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..
- Problem solving skills and ability to correlate statistical findings with potential process improvement opportunities.
- Experience in planning and interpreting results for DOE.
- Authorization to work in the United States without sponsorship.
- 5+ years’ experience in a GMP and/or ISO13485 development environment.
- Understanding of FDA guidelines for analytical performance studies and clinical validation.