Bristol Myers Squibb Associate Director Non-Clinical Statistics in New Brunswick, New Jersey
PRINCIPAL OBJECTIVE OF THE POSITION:
The Associate Director of Statistics is responsible for the leading the global statistics central group supporting drug substance, API, drug product for the BMS internal and external manufacturing network. This position reports to the Head of Data systems, Monitoring and Analytics in Manufacturing Sciences and Technology, within Bristol-Myers Squibb's Global Product Development and Supply.
MAJOR DUTIES AND RESPONSIBILITIES:
Leads and manages specification setting statistical support for API and biologics Drug substance and Drug product.
Provides statistical and data analysis SME support for complex data analysis requests, such as critical investigations, stability trending or yield improvement initiatives.
Collaborates with global and site functions to identify areas of improvement for yield and robustness.
Defines and leads the global statistics training program for MS&T.
Maintains awareness of external trends and represents BMS at industry forums.
Assumes the leadership role in providing statistical expertise and participates in developing strategies align with regulatory expectations and business needs.
Provides guidance and direction to other statisticians in resolving problems, handling data, and determining techniques to use for incoming projects.
This position will sit at the New Brunswick, NJ facility.At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference. QUALIFICATIONS:
Requires a PhD in Statistics or Engineering (or other relevant discipline) with a minimum of 10 years of experience in supporting biopharmaceutical manufacturing.
The preferred candidate will have: Experience in a cGMP-regulated environment, preferably gained through direct support of commercial manufacturing.
Thorough knowledge of statistical process tools, and direct experience in experimental design.
Extensive knowledge of FDA / EMEA CGMPs and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution.
Outstanding problem-solving skills.
Ability to engage and motivate teams, outstanding ability to communicate and build collaborations.
Experience leading and managing groups of PhD/MS/BS statisticians. CONTACTS: The Associate Director of Statistics, MS&T, is in direct contact with senior leaders across the BMS network, including heads of MS&T, Manufacturing and Quality. Occasional interactions occur with external industry and regulatory representatives. WORKING CONDITIONS: Principal assignment is in a modern office facility; supporting the global BMS manufacturing network. Due to this, business-related travel is required, not generally exceeding five nights per month. DECISION MAKING: Exercise sound judgment in making decisions and recommendations within generally defined practices and policies, and notify management when necessary. Leads statistical support and specification setting across the manufacturing network. Works on abstract problems across functional areas of the business. Identifies and resolves fundamental issues. Erroneous decisions will have a serious impact on the overall success of division operations. SUPERVISION RECEIVED: Works with minimal supervision on the accomplishment of agreed-upon goals and objectives.At Bristol-Myers Squibb, we’re creating innovative medicines for patients who are fighting serious diseases. We’re also nurturing our own team with inspiring work and challenging career options. No matter our role, each of us makes a contribution. And that makes all the difference. SUPERVISION EXERCISED: Incumbent has supervision over a staff of 9-10 full-time employees.
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, disability or protected veteran status.