Description:
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.
This position is responsible for providing statistical analysis/advanced analytics, direction, and training to service clients in Global Product development & Supply (GPS). Support and guidance about study design and data analysis are provided worldwide to the BMS facilities.
Duties & Responsibilities
- Leads Statistics and advanced analytics projects and communicates strategies aligned with regulatory expectations and business needs.
- Provides statistics/analytics expertise and drives innovation across a broad range of Non-Clinical areas including biopharma manufacturing, late-stage process development, regulatory submissions, tech transfer, validation, clinical supplies, and quality control.
- Supports Global Product Development & Supply including facilities worldwide
- Develops and applies advanced analytics tools and related business processes to support critical initiatives.
- Provides guidance and training to service clients in Global Product Development & Supply and other statisticians.
- Builds strategic relationship with collaborators and promote statistical thinking in decision-making.
- Contributes to the globalization, improvement, and standardization of processes, procedures, and systems in relation to Statistics while maintaining flexibility where required.
- Keep abreast of new developments in advanced analytics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities.
- Acts as a departmental interface with Information Technology on system-related projects.
- Supports the BMS values.
Experience / Knowledge Desired
- M. S. or Ph. D. in Statistics, Applied Mathematics, or Chemical Engineering majors with significant academic training in Statistics/Data Analytics.
- Ph.D. with at least 5 years’ experience, or M.S. with at least 8 years’ experience, in the biopharmaceutical industry with technical knowledge in the following areas: biopharma commercial manufacturing process modeling, specifications setting, stability analysis, analytical science support.
- Ability to work with a wide range of technically and culturally diverse individuals.
- Ability to analyze and interpret scenarios, and through effective questioning and data analysis provide answers and appropriate courses of action.
- Knowledge of FDA / EMEA CGMPs and knowledge of other global regulatory compliance guidelines (e.g., ICH) for drug manufacturing, packaging, and distribution.
- Proficiency in major analytics programming, software packages, and platforms (e.g., R, SAS, and JMP). Knowledge of Spotfire and Python is a plus.
- Demonstrates effectiveness with cross-functional project management
- Able to work independently or as a team member to meet goals, objectives, and commitments.
- Demonstrates ability to effectively communicate technical information in an understandable, rational, and concise manner.
- Experience working directly with manufacturing and marketing leaders, technical experts, Quality, R&D, and Regulatory personnel at domestic and international sites.