Bristol-Myers Squibb Company

Manager, Non-Clinical Statistics

Location
New Brunswick, NJ, US
Posted
Dec 08, 2018
Ref
R1507375
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 Product Development & 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 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 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: specifications, 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.