Biostatician

: Responsible for establishing statistical methodology on product development, clinical trials, validations, and process improvements. Responsible for supporting the organization in statistical methodology and analysis. Responsible for ensuring the statistical validity of regulatory submissions and publications.

•Works with company personnel to identify, isolate and correct technical challenges for improving product and process reproducibility.

•Serves as statistical methodology expert for the organization

•Provides input as requested for changing procedures and updating processes

•Improves understanding and utilization of statistical tools and methods throughout the organization.

•Writes statistical sections of protocols (development, validation, clinical trials) and Marketing materials.

•Interacts with regulatory authorities on statistical regulatory issues as required.

•Creates experiment design plans.

•Performs sample size calculations and provides justification of sample sizes.

•Complies statistical methods for studies including but not limited to, validations, clinical studies, and process
data analysis.

•Provide data analysis for research, process and product development, and manufacturing processes to determine the appropriate statistical method.

•Communicates statistical issues and solutions with pre-clinical and clinical development team.

•Assist in quality review of data to confirm it’s suitable for intended purpose or analysis.

•Develops data collection systems to facilitate efficient data analysis.

•Reviews clinical study data to confirm appropriateness.

•Verifies methodologies used for data collection and analysis.

•Monitor new methodologies and statistical techniques for the statistical analysis of clinical data.

•Develops and presents training and training materials on statistics and related topics.

•Assists with the evaluation, purchase, and implementation of statistical and Process Control System software and related tools.
REQUIREMENTS
EDUCATION/EXPERIENCE: Bachelor’s Degree Statistics, Biostatistics, Mathematics or Computer Science required (Master’s Degree preferred).Five plus years of medical device industry experience or equivalent preferred. Strong communication and people skills are essential. Multitasking skills and detail orientation are required.