Associate Director, Analysis Standards Governance (R1556899-en-us-3)
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.
The Associate Director Analysis Standards Governance 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.
- Lead initiatives 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
- Fosters a continuous improvement and innovation culture with respect to the current and future data standards and related infrastructure to optimize the user experience across GBDS and with internal and external partners.
- Propose, develop, and drive forward innovative approaches to streamline metadata implementation for GBDS as well as Global Drug Development.
- Partner with and influence senior leaders in the organization and garner alignment for new and modified analysis standards as well as ensuring end to end alignment with upstream and downstream standards.
- Responsible for the scientific correctness and applicability of the clinical analysis standards in support of the various clinical trial processes.
- 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 the development, implementation, maintenance, training, communications and continuous improvement of clinical analysis standards supporting the GBDS’ portfolio of clinical trials.
- Expertise on regulatory requirements (e.g. FDA, PMDA) pertaining to submitting clinical trial data to regulatory authorities
- 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.
- 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
- Bachelors Degree in statistics, mathematics, computer science or other scientific field. Masters degree preferred.
- Minimum of 8 years in pharmaecutical industry
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.
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