The Sr. Biostatistician performs data analysis, statistical experimental design, sampling techniques, and sample size determination in support of product development, clinical trials, regulatory submissions, and product quality. Applies current statistical methods when appropriate, and develops new methods when necessary. Exercises judgment within generally defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Reviews and writes requirements, designs, and documentation in support of clinical trials and regulatory submission. Provides statistical training to research and clinical associates, engineers, scientists, and other non-statistical professionals. Writes reports and makes oral presentations as required. Normally receives no instruction on routine work, general instructions on new assignments.
Duties and Responsibilities:
- Consults and provides guidance on statistical issues to staff, researchers and clients.
- Provides statistical experimental design and data analysis in support of developmental activities in device and product.
- Plans, reviews, and analyzes clinical studies.
- Provides statistical support to business to facilitate strategic decision making.
- Applies and develops innovative statistical methods when necessary.
- Documents results according to established company practices.
- Conducts data review; writes reports and presents analyses and interpretation to internal customers.
- Interacts and communicates with internal scientists, engineers, technical staff, and business partners on an ongoing basis.
- Keeps abreast of the basic requirements on regulatory issues in the area of statistics.
- Teaches technical courses and trains staff and co-workers.
- Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
- Performs other related duties and assignments as required.
Education and Experience:
- Requires a MS or a Ph.D. degree in Statistics, Biostatistics or a related discipline with 3 - 5 years of experience.
- Experience in the medical device or other regulated industry with a plus.
- Strong knowledge in experimental design and clinical trial design.
- Knowledge and experience in regulatory submission of class III devices, PMA and/or NDA.
- Expertise in standard statistical techniques (e.g. experimental designs, statistical modeling, exploratory data analysis, sample size determination, statistical simulation).
- Knowledge of the statistics in mathematical statistics, nonparametric statistics, applied probability, multivariate analysis, linear and nonlinear models, generalized linear models, Bayesian inference, categorical data analysis, and statistical quality control.
- Knowledge of algorithms, optimization, simulation, Six Sigma, and survey sampling are strongly desirable.
- Working knowledge of SAS or R is required. Knowledge of other programming languages desirable.
- Knowledge/Coursework in physical, biological, or social sciences a plus.
- Demonstrated ability to work within a matrix organization.
- Strong interpersonal skills, demonstrated capability of multitasking ability.
- Strong oral and written communication skills.
- Strong problem solving skills and attention to detail.
- Effective time management.