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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: careers.bms.com/working-with-us .

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.

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

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility 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.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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

Company: Bristol-Myers Squibb

Req Number: R1587168

Updated: 2024-11-25 03:19:46.136 UTC

Location: Boudry-CH

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.