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Position: Senior Manager, Senior Statistician
Institution: Bristol-Myers Squibb Company
Location: Switzerland, Ireland, United States
Duties: Leads Statistics projects and communicates strategies align with regulatory expectations and business needs; Provides statistical expertise and analyses across a broad range of Non-Clinical area’s including development, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, and quality control; Supports Global Product Development & Supply including facilities worldwide; Focuses on statistical needs for late stage process development, regulatory submissions, and launch to further the pipeline
Requirements: Ph.D. with at least 3 years’ experience, or M.S. with at least 6 years’ experience, in biopharmaceutical industry with technical knowledge in the following areas: specifications, stability and biopharma commercial manufacturing process; Ability to work with a wide range of technically and culturally diverse individuals; Ability to analyze and interpret scenarios, and through effective questioning and data analysis provide answers and appropriate courses of action; Knowledge of FDA/EMEA CGMPs and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution
   
Text: Learn about our safety approach to COVID-19 > Sign In logo globe icon Global Careers Home Working with Us Featured Opportunities Biologics Business Insights & Analytics Cell Therapy (CAR T) Devens Drug Discovery and Translational Medicine Immunology Medical Science Liaison Military and Veterans Oncology R&D Physicians Early Career Advanced Degree Programs Co-Ops Internships Leadership Development Programs Career Stories Events Search Jobs Careers Global Core Languages English / Español-España / Español-Latin / Português do Brasil / 中文 简体 (中国) / 中文 繁體 / 한국어 (대한민국) / 日本語 (日本) / Français (France) / Deutsch / Italiano Americas Argentina Spanish Brazil Portuguese Canada English / French Chile Spanish Colombia Spanish Peru Spanish United States English Mexico Spanish Asia Pacific Australia English China Simplified Chinese India English Japan Japanese Korea Korean New Zealand English Taiwan Traditional Chinese Europe Austria German Belgium English / Dutch / French Czech Republic English Denmark Danish Finland Finnish France French Germany German Greece Greek Hungary Hungarian Ireland English Italy Italian Luxembourg English Netherlands Dutch / English Norway Norwegian Poland Polish Portugal Portuguese Romania Romanian Russia Russian Spain Spanish Sweden Swedish Switzerland German / French / English United Kingdom English Middle East Israel English Turkey Turkish Back Senior Manager, Senior Statistician Devens, Massachusetts; Boudry, Switzerland; Cruiserath, Ireland; New Brunswick, New Jersey; Phoenix, Arizona Manufacturing/Ops R1551602 Full Time 01/20/2022 mail_outline Get future jobs matching this search or 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. Position Overview: This position is responsible for providing statistical analysis, direction and training to service clients in Global Product development & Supply (GPS). Support and guidance in relation to study design and data analysis is provided worldwide to the BMS facilities. Key Responsibilities: Leads Statistics projects and communicates strategies align with regulatory expectations and business needs. Provides statistical expertise and analyses across a broad range of Non-Clinical area’s including development, tech transfer, validation, PAIs, clinical supplies, manufacturing, transportation, and quality control. Supports Global Product Development & Supply including facilities worldwide Focuses on statistical needs for late stage process development, regulatory submissions, and launch to further the pipeline. Develops and applies advanced statistical tools and related business processes, such as multivariate analysis and Bayesian applications to support critical initiatives. Provides guidance and training to service clients in Global Product Development & Supply and other statisticians. Builds strategic relationship with collaborators and promote statistical thinking in decision making. Contributes to the globalization, improvement and standardization of processes, procedures and systems in relation to Statistics while maintaining flexibility where required. Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities. Acts as departmental interface with Information Technology on system related projects. Performs programming (e.g., SAS) as needed.Supports the BMS BioPharma Behaviors. Education & Experience: Ph.D. with at least 3 years’ experience, or M.S. with at least 6 years’ experience, in biopharmaceutical industry with technical knowledge in the following areas: specifications, stability and biopharma commercial manufacturing process. Ability to work with a wide range of technically and culturally diverse individuals. Ability to analyze and interpret scenarios, and through effective questioning and data analysis provide answers and appropriate courses of action. Knowledge of FDA / EMEA CGMPs and knowledge of other global regulatory compliance guidelines (e.g. ICH) for drug manufacturing, packaging and distribution. Proficiency in major statistical software packages (e.g., SAS, R, MINITAB, and JMP). Knowledge in Spotfire and Python is a plus. Demonstrated effectiveness with cross-functional project management Able to work independently or as a team member to meet goals, objectives and commitments. Demonstrated ability to effectively communicate technical information in an understandable, rational, and concise manner. Experience working directly with manufacturing and marketing leaders, technical experts, Quality, R&D, and Regulatory personnel at domestic and international sites. 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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. Apply Share Job Equal Employment Opportunity / Disability Assistance Legal Notice Candidate Privacy Policy Contact Us/FAQs Powered by iCIMS © 2022 Bristol-Myers Squibb Company Follow Us
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