Job Description

Job Description Summary

The Senior Statistician will provide statistical support for clinical trials and some pre-clinical trials as needed. The projects complexity will vary but this work is essential to find the best possible outcomes for those that rely on our products.

Job Description

Be part of something bigger!

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

The Senior Statistician will provide statistical support for clinical trials and some pre-clinical trials as needed. The projects complexity will vary but this work is essential to find the best possible outcomes for those that rely on our products.

Duties:

Collaborate with clinical and project teams, plan and analyze studies/experiments; use statistical knowledge to support and guide business decisions

Program, document, and validate software code to execute data handling tasks, perform data analysis, design statistical approaches to handle non-standard statistical problems, and produce data visualization results

Present findings to Leadership

Provide statistics results for projects to meet schedules and goals for multiple businesses and platforms

Develop/revise statistical analysis plans independently except for unusual situations, which might require consultation

Identify and work to implement process improvement initiatives within the Statistics function or across related functions

Keep abreast of new statistical developments and regulatory guidance; survey related fields for techniques that could be adapted to BD’s needs

May make presentations or contribute to publications for industry-related conference and journals

Skills and Requirements:

Demonstrated competence in the application of statistical techniques used in product development and clinical trials is required. In addition, demonstrated competence in the application of statistical techniques used in other areas such as manufacturing operations, quality, regulatory, and continuous improvement is a plus.

Ability to program, document, and validate statistical software code in R is required

Knowledge and experience working in a reproducible research environment is preferred.

Working knowledge of applicable regulations and the ability to apply without supervision is preferred.

Ability to exercise strong professional judgment is required.

Demonstrated strong leadership skills and the ability to influence without direct authority are required within the function.

Ability to assist in delivering training to non-statistical professionals is required.

Demonstrated capability of working on multiple projects at one time is required.

Strong oral and written communication skills are required.

Strong interpersonal skills are required. Specifically, cross functional collaboration, listening and negotiation skills are essential.

Required:

A minimum of a Master’s degree is required in Statistics, Biostatistics, or related field (math, physics, computer programming) with 3 or more years of proven experience in a regulated industry with device and/or healthcare industry. (PhD preferred with 1or more years of experience).

Experience working with FDA and/or other regulatory bodies outside of submission work is preferred (i.e. guidance document generation, meetings/clinics.)

Experience providing statistical consulting for non-statisticians is preferred