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.
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, 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. Performs statistical analysis on different pharmaceutical datasets; interact with 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 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 applies varies 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.
1. Ph. D. in STEM majors including Statistics, Applied Mathematics, Engineering etc. with significant academic training in quantitative analysis. Or M. S. with a minimum of at least 3 years experience.
2. Proficiency in major statistical software / programming (e.g., SAS, R, Python, 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.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to . Visit[Register to View] target="_blank"> [Register to View] to access our complete Equal Employment Opportunity statement.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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