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The Senior Manager, Innovation Strategy and Solutions Lead (Statistical programming&Technology) supports the framing, assessment, recommendation, and implementation of innovative strategies and solutions to bring efficiencies and automation to the clinical development process, under the direction of the Head Analysis Standards & Innovation. The incumbent will focus on innovative approaches to streamline processes and technology implementation with an ultimate goal of complete end to end solutioning. To that end, the job holder will work across Global Biometrics and Data Sciences departments, as well as cross functionally, including, but not limited to, Global Data Management & Centralized Monitoring, Clinical, Regulatory, Medical Writing, etc.
Responsibilities
Support the framing, assessment, and recommendation of internal and external innovation initiatives, in collaboration with stakeholders across GBDS, to develop and implement more efficient and effective solutions for the development and maintenance of clinical development within biometrics and for the implementation of these solutions for use in clinical trials
Provide strategic input to help drive projects to optimize the user experience across GBDS and with internal and external partners, fostering a continuous improvement and innovation culture with respect to the current and future solutions and related infrastructure
Collaborate with GBDS teams to propose, develop, and drive forward innovative approaches to streamline implementation for GBDS as well as Global Drug Development
Responsible for the scientific correctness and applicability of the solutions in support of the various clinical trial processes.
Responsible for ensuring that processes and solutions are structured and governed in a manner that is well aligned with stakeholder processes in order to maximize efficiencies and value.
Expertise on regulatory requirements (e.g. FDA, PMDA) pertaining to submitting and analyzing clinical trial data to regulatory authorities
Bring to bear experience in data, digital, technology, and functional areas of biopharma to identify and prioritize new capability builds, in collaboration with business partners (e.g., IT, Procurement)
Take ownership of internal and external teams to support ideas from conception to implementation
Strategic partnering with leads, user community, and departmental/external stakeholders to identify innovation, automation, and continuous improvement opportunities. Proposes, evaluates and develops solutions and strategies that drive competitive advantage.
Serves as a departmental resource in areas of technical expertise in the Clinical Data Interchange Standards Consortium (CDISC) standards related to the protocol development, statistical analysis, statistical programming and clinical study report authoring.
Support development, implementation, maintenance, training, communications and continuous improvement of solutions supporting the GBDS\\xe2\\x80\\x99 portfolio of clinical trials.
Maintains up to date knowledge of industry, functional and departmental processes, trends and technologies ensuring optimal implementation and adoption to support current and future needs.
Ensures continued compliance with required company and departmental training, time reporting, and other business/operational processes as required for the position.
Support design, development, deployment of innovation projects along with technology teams.
Support innovation roadmap and strategic implementation and change management plans.
Engages a network of internal and industry experts and leads the development of best practices and implementation of innovative solutions
Actively engage as a member of industry organizations such as CDISC and PhUSE and work with industry experts to leverage and exchange knowledge and experience on regulations (e.g. FDA, PMDA) pertaining to the requirements for regulatory authorities
Degree Requirements
Bachelors Degree in statistics, mathematics, computer science or other scientific field. Masters degree preferred.
Experience Requirements
Minimum of 8 years in pharmaceutical industry.
If you come across a role that intrigues you but doesn\\xe2\\x80\\x99t 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 \\xe2\\x80\\x9cTransforming patients\\xe2\\x80\\x99 lives through science\\xe2\\x84\\xa2 \\xe2\\x80\\x9d, 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.
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