Job Description 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.
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.