Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
This position is responsible for providing statistical analysis, direction and training to service clients in Global Manufacturing & Supply (GMS). Support and guidance in relation to study design and data analysis is provided worldwide to the BMS facilities. This position also assists R&D and other BMS business units in study design and statistical analyses, as needed.
This Manager, Non-Clinical Statistics is responsible for:
- Assumes the leadership role for Global Statistics projects and communicates strategies align with regulatory expectations and business needs.
- Provides statistical expertise and analyses across a broad range of Non-Clinical area’s including development, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, and quality control.
- Supports Global Manufacturing & Supply including facilities worldwide and assists R&D and other BMS business units in study design and statistical analyses.
- Focuses on statistical needs for new product development, regulatory submissions, and launch to further the pipeline.
- Develops and applies advanced statistical tools and related business processes, such as multivariate analysis and Bayesian applications to support critical initiatives.
- Provides guidance and training to service clients in Global Manufacturing & 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 statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities.
- Acts as departmental interface with Information Technology on system related projects. Performs programming (e.g., SAS) as needed.
- Supports the BMS BioPharma Behaviors.
Experience / Knowledge Desired:
- M. S. or Ph. D. in Statistics, Applied Mathematics, or Engineering majors with significant academic training in Statistics.
- Proficiency in major statistical software packages (e.g., SAS, R, MINITAB, and JMP).
- A minimum of 3 years experience in pharmaceutical industry with technical knowledge in the following areas:
- stability and statistics.
- 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.
- 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 of working directly with manufacturing and marketing leaders, technical experts, Quality, R&D, and Regulatory personnel at domestic and international sites.
A little about us:
Our shared focus to become a Diversified Specialty BioPharma company is driving us forward. Pioneering in new areas of research.