Manager, Statistician

  • Training/Education
  • Ireland
  • Posted 11 months ago

Bristol-Myers Squibb

Job title:

Manager, Statistician

Company

Bristol-Myers Squibb

Job description

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: .

Bristol Myers Squibb Ireland

Bristol Myers Squibb has been in operation in Ireland since 1964, employing over 650 people across a range of activities and business units

Located in Dublin, Cruiserath Biologics Campus, a one billion Multi-Product Cell Culture Biologics Manufacturing facility plays a central role in the Global Product Development and Supply (GPS) network as the company’s first European biologics manufacturing facility. This state of the art facility will produce multiple therapies for the company’s growing biologics portfolio. Global Biologics Laboratory (GBL) responsible for the release testing of Biologics Drug product for the network, is also based on the Cruiserath Biologics Campus.

BMS Cruiserath has been awarded “Biopharma Company of the Year 2019” in the Irish Pharma Industry Awards and is certified as a Great Place to Work since 2017, including as a Great Place to Work for Women in 2020 and 2021.

For more information about Bristol Myers Squibb, visit us at BMS.com/ie

Job 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

  • Builds and fosters relationships with customers, stakeholders, and support groups globally to understand their statistical needs and determines sound statistical techniques for use.
  • 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.
  • Supports analytical teams in QC and Analytical Sciences & Technology for method performance monitoring and reference standard qualification
  • 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.
  • Conducts thorough and careful analysis of data, gathers critical information, and provides appropriate recommendations and solutions based on corresponding statistical analyses and business needs.
  • Demonstrates strong statistical skills while thinking in a clear, decisive manner. Reaches independent, logical solutions.
  • Represents Global Statistics at product development, product protocol, and management meetings.
  • Contributes to the globalization, improvement and standardization of processes, procedures and systems in relation to Statistics while maintaining flexibility where required.
  • Furthers the statistical awareness and statistical process control competency of other BMS personnel; participates in their training and development, as required.
  • Acts as departmental interface with Information Technology on system related projects. Performs programming (e.g., SAS) as needed.
  • Creates, communicates, and supports the highest commitment to quality and compliance.
  • Supports the BMS BioPharma Behaviors.

Qualifications, Knowledge and Skills Required

  • Ph. D. in Statistics, Data Analytics, or Engineering majors with significant academic training in Statistics and machine learning.
  • Proficiency in major statistical software packages (e.g., SAS, R, Python, and JMP)
  • Ability to work with a wide range of technically and culturally diverse individuals.
  • Ability to analyze and interpret scenarios, and through effective study design and statistical analysis provide answers and appropriate courses of actions
  • Knowledge of FDA/EMEA cGMPs and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution.
  • Highly organized.
  • Able to work independently or as a team member to meet goals, objectives and commitments.
  • Demonstrates ability to effectively communicate technical information in an understandable, rational, and concise manner.
  • Ability to integrate statistical and quality control concepts.
  • Some background in the sciences to facilitate a subjective understanding of the problems at hand.

Why you should apply

  • You will help patients in their fight against serious diseases
  • You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package

#LI-Hybrid

If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Expected salary

Location

Ireland

Job date

Fri, 26 Jan 2024 03:59:33 GMT

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