Bristol Myers Squibb Senior Statistician in Devens, Massachusetts
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
This Senior Statistician is responsible for:
• Leads 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
• Focuses on statistical needs for late stage process 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.
Ph.D with at least 3 years’ experience, or M.S. with at least 6 years’ experience, in biopharmaceutical industry with technical knowledge in the following areas: specifications, stability and biopharma commercial manufacturing process.
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 statistical software packages (e.g., SAS, R, MINITAB, and JMP). Knowledge in 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 of working directly with manufacturing and marketing leaders, technical experts, Quality, R&D, and Regulatory personnel at domestic and international sites.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Company: Bristol Myers Squibb
Req Number: R1533121-en-us
Updated: 2020-11-28 03:09:24.064 UTC
Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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