Job Description Summary

Provide statistical support for clinical trials and for other functions such as R&D, manufacturing, quality, and marketing as needed. Consult with clinical and project teams, plan and analyze clinical studies and other types of experiments or surveys. May participate in Global Clinical Development (GCD) project teams for large and complex clinical trials or for critical functional projects. Identify and fulfill training needs for non-statistical professionals. The principal statistician is recognized internally as a subject matter expert in the area of statistics.

Job Description

Primary Responsibilities

• Serve as primary statistician on multiple studies: provide input, support and guidance on study planning/design, conduct, analysis and reporting, in order to optimize gathering and use of data to clearly answer business critical questions while ensuring that results are interpreted and reported in a valid scientific way.
• Use statistical knowledge to influence business and strategic decisions; interpret statistical results and present analyses and interpretations to internal and external customers.
• Participate in the development of protocols, develop statistical analysis plans and prepare formal written statistical reports/documents for distribution within and outside the department.
• Program, document, and validate software code to execute data handling tasks, perform data analysis, and produce data visualization results.
• Provide technical leadership and mentor junior statisticians.
• Provide statistical support to the planning, authoring, and review of manuscripts, publications and other scientific data disclosures.

Skills

• Demonstrated competence in the application of statistical techniques used in clinical trials is required.  Experience in statistical techniques related to any of the following is a plus: real-world evidence generation, data science, product development, manufacturing operations, quality. 
• Ability to program, document, and validate statistical software code in at least one statistical programming language, such as R or SAS, is required.  Knowledge of reproducible research is a plus.
• Knowledge of applicable regulations and ability to interpret regulations/standards is required.  Ability to make appropriate comments to proposed guidelines and regulations on behalf of function is a plus.
• Ability to work on issues of diverse scope, where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends, medical practice and regulatory issues is required.
• High level of organizational savvy, ability to exercise strong professional judgment and ability to serve as a role model within the organization is required.
• Strong interpersonal skills are required.  Specifically, communicating statistical concepts to non-statisticians, cross functional collaboration, listening and negotiation skills are critical.

Education

A minimum of a Master’s degree required in Statistics, Biostatistics, or related field.  A PhD is preferred. Equivalent education or experience will be considered.

Experience

5+ years of statistical experience in a regulated industry with device and/or healthcare industry is required. 

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Primary Work Location

USA NJ - Franklin Lakes

Additional Locations

Work Shift