Company: Bristol-Myers Squibb
Location: New Brunswick
Posted on: July 3, 2019
Summary: The incumbent will provide statistical analyses and
training to support Global Product Development & Supply (GPS) 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 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.
Builds and fosters relationships with customers, stakeholders, and
support groups globally to understand their statistical needs and
determines sound statistical techniques for use. 2. 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. 3. Supports analytical teams in QC and Analytical
Sciences & Technology for method performance monitoring and
reference standard qualification 4. 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. For example, determining specifications, process
capability, sampling plans and expiry/retest periods. 5. Conducts
thorough and careful analysis of data, gathers critical
information, and provides appropriate recommendations and solutions
based on corresponding statistical analyses and business needs. 6.
Demonstrates strong statistical skills while thinking in a clear,
decisive manner. Reaches independent, logical solutions. 7.
Represents Global Statistics at product development, product
protocol, and management meetings. 8. Contributes to the
globalization, improvement and standardization of processes,
procedures and systems in relation to Statistics while maintaining
flexibility where required. 9. Furthers the statistical awareness
and statistical process control competency of other BMS personnel;
participates in their training and development, as required. 10.
Acts as departmental interface with Information Technology on
system related projects. Performs programming (e.g., SAS) as
needed. 11. Creates, communicates, and supports the highest
commitment to quality and compliance. 12. Supports the BMS
BioPharma Behaviors. Education: 1. M. S. with a minimum of at least
3 years experience 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. Ability to work with a wide range of technically and culturally
diverse individuals. 2. Ability to analyze and interpret scenarios,
and through effective study design and statistical analysis provide
answers and appropriate courses of action. 3. Knowledge of FDA/EMEA
cGMPs and knowledge of other global regulatory compliance
guidelines (e.g. ICH) for drug manufacturing, packaging and
distribution. 4. Highly organized. 5. Able to work independently or
as a team member to meet goals, objectives and commitments. 6.
Demonstrates ability to effectively communicate technical
information in an understandable, rational, and concise manner. 7.
Ability to integrate statistical and quality control concepts. 8.
Some background in the sciences to facilitate a subjective
understanding of the problems at hand.
Keywords: Bristol-Myers Squibb, New Brunswick , Statistician, Other , New Brunswick, New Jersey
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