Associate Director, Non-Clinical Statistics (Devens, MA or New Brunswick, NJ)

Bristol-Myers Squibb Devens, MA

About the Job

Description:

At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients. 

 

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.

 

This role can be located in Devens, MA or New Brunswick, NJ.  We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless.  It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.

 

The incumbent will provide statistical expertise, analyses, and training to support Global Manufacturing & Supply (GMS) and late stage development to deliver process and method robustness in ensuring product quality and compliance Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses. Support and guidance in relation to study design and data analysis will be provided to BMS functions worldwide, including small molecule and biologics development, manufacturing, and supply.

 

Summary\:

The incumbent will provide statistical expertise, analyses, and training to support Global Manufacturing & Supply (GMS) and late stage development to deliver process and method robustness in ensuring product quality and compliance Areas of support include development, process improvement, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, health authority filings, and regulatory responses.  Support and guidance in relation to study design and data analysis will be provided to BMS functions worldwide, including small molecule and biologics development, manufacturing, and supply. 

  

Major Duties and Responsibilities\:

1.    Assumes the leadership role in providing statistical expertise and participates in developing strategies align with regulatory expectations and business needs.
2.    Assist in managing allocation of resources and setting of priorities to effectively meet priorities and objectives; tracks departmental completion of assignments.
3.    Assists in definition of roles and responsibilities, fosters effective team skills, and insures robust results are produced.
4.    Provides guidance and direction to other statisticians in resolving problems, handling data, and determining techniques to use for incoming projects.
5.    Acts as a subject matter expert in authoring / reviewing policies and directives related to Statistics.
6.    Builds and fosters relationships with customers, stakeholders, and support groups globally to understand their statistical analysis needs and determines sound statistical techniques for use.
7.    Collaborates with process analytical teams and subject matter experts in Manufacturing and Manufacturing Sciences & Technology to design studies and analyze complex datasets for process robustness and improvement.
8.    Supports analytical teams in QC and Analytical Sciences & Technology for analytical robustness and continued analytical verification.

9.    Develops and selects appropriate statistical methods for the design and analysis of studies and programs in order to assure batch compliance and prevent rejections, reworks, complaints, and product recalls on a worldwide basis.
10.    Conducts thorough and careful analysis of data, gathers critical information, and provides appropriate recommendations and solutions based on corresponding statistical analyses and business needs.
11.    Represents Global Statistics at management and regulatory agency meetings, when necessary. Prepares responses on statistical issues raised by regulatory agencies pertaining to BMS submissions and inspections.
12.    Furthers the statistical awareness and increases the competency of statisticians and other BMS personnel; participates in their training and development, as required. 
13.    Contributes to the globalization, improvement and standardization of processes, procedures and systems in relation to Statistics while maintaining flexibility where required.
14.    Participates in efforts to influence industry practices on statistical and operational issues. 
15.    Creates, communicates, and supports the highest commitment to quality and compliance.
16.    Supports the BMS BioPharma Behaviors.
Qualification:

Education\:
1.    M. S. or Ph. D. in Statistics, Applied Mathematics, or Engineering majors with significant academic training in Statistics. 
2.    Proficiency in major statistical software packages (e.g., SAS, R, MINITAB, and JMP).  

 

Experience / Knowledge Desired\:
1.    A minimum of 7 years experience in pharmaceutical industry with technical knowledge in the following areas\: specifications, stability and statistics.
2.    Ability to work with a wide range of technically and culturally diverse individuals.
3.    Ability to analyze and interpret scenarios, and through effective questioning and data analysis provide answers and appropriate courses of action.
4.    Extensive knowledge of FDA / EMEA, CGMPs, Quality Assurance principles, and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution. 
5.    Demonstrates effectiveness with cross-functional project management.
6.    Highly organized.
7.    Able to work independently or as a team member to meet goals, objectives and commitments.
8.    Demonstrates ability to effectively communicate technical information in an understandable, rational, and concise manner.
9.    Extensive experience of working directly with manufacturing and marketing leaders, technical experts, Quality, R&D, and Regulatory personnel at domestic and international sites.
10.    Ability to integrate statistical and quality control concepts.
11.    Background in the sciences and understanding of pharmaceutical methods, processes, products, and operations to facilitate an understanding of the problems at hand. 

 

Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers