Innovation, Strategy, & Solutions Lead

at  BristolMyers Squibb

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.
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The Associate Director Standards & Innovation supports the development, maintenance and implementation of analysis standards, under the direction of the Head Analysis Standards Governance, to improve the efficiency of clinical research analysis and reporting processes and improve the consistency, quality, and value of clinical trial information globally. The incumbent will focus on innovative approaches to streamline metadata 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

• Lead the framing, assessment, and recommendation of internal and external innovation initiatives, in collaboration with executive leaders across GBDS, to develop and implement more efficient and effective solutions for the development and maintenance of clinical analysis standards and for the implementation of these standards for use in clinical trials
• Provide strategic leadership and 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 data standards and related infrastructure
• Collaborate with GBDS teams to propose, develop, and drive forward innovative approaches to streamline metadata implementation for GBDS as well as Global Drug Development
• Responsible for the scientific correctness and applicability of the clinical analysis standards in support of the various clinical trial processes.
• Responsible for ensuring that standards 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 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 lead 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 clinical analysis standards supporting the GBDS’ 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.
• Define innovation roadmap and support strategic implementation and change management plans.
• Engages a network of internal and industry experts and leads the development of best practices and implementation of analysis standards
• Actively engage as a member of industry standards 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 submitting clinical trial data to regulatory authorities

Degree Requirements

• Bachelors Degree in statistics, mathematics, computer science or other scientific field. Masters degree preferred.

Experience Requirements

• Minimum of 12 years in pharmaceutical industry.

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.

• Lead the framing, assessment, and recommendation of internal and external innovation initiatives, in collaboration with executive leaders across GBDS, to develop and implement more efficient and effective solutions for the development and maintenance of clinical analysis standards and for the implementation of these standards for use in clinical trials
• Provide strategic leadership and 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 data standards and related infrastructure
• Collaborate with GBDS teams to propose, develop, and drive forward innovative approaches to streamline metadata implementation for GBDS as well as Global Drug Development
• Responsible for the scientific correctness and applicability of the clinical analysis standards in support of the various clinical trial processes.
• Responsible for ensuring that standards 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 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 lead 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 clinical analysis standards supporting the GBDS’ 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.
• Define innovation roadmap and support strategic implementation and change management plans.
• Engages a network of internal and industry experts and leads the development of best practices and implementation of analysis standards
• Actively engage as a member of industry standards 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 submitting clinical trial data to regulatory authoritie