Senior Manager, Statistical Programming

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 Senior Manager 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 the operational maintenance of and metrics for analysis and submission standards. The person in this position will engage across Global Biometrics and Data Standards and some cross functional colleagues including but not limited to Global Data Management & Centralized Monitoring.

This position in particular is to fill the SDTM Steward role which is ultimately accountable for driving the development of SDTM within GBDS. The incumbent will focus on SDTM metadata management, governance, process, efficiency development, and innovative solutions. The SDTM steward is seen as the GBDS expert in SDTM and provides support to GBDS study teams and vendors for implementation questions.

Position Responsibilities

· Responsible for the scientific correctness and applicability of the clinical analysis standards in support of the various clinical trial processes.

· Expertise in at least one of the Clinical Data Interchange Standards Consortium (CDISC) standards (e.g. Study Data Tabulation Model (SDTM)) related to the protocol development, statistical analysis, statistical programming or clinical study report authoring.

· Lead or support 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.

· Support the development, implementation, maintenance, training, communications and continuous improvement of clinical analysis standards supporting the GBDS’ portfolio of clinical trials.

· Significant knowledge of 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.

· 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.

· Starts to build a network of internal and industry experts to support 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

· Ability to influence peers 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.

Degree and Experience Requirements

· Bachelor's Degree in statistics, mathematics, computer science or other scientific field. Masters degree preferred.

· Minimum of 6 years in pharmaceutical industry

Key Competency Requirements

· Strong collaboration and problem-solving skills

· Pro-active and vocal in meetings

· Proven leadership roles on small continuous improvement initiatives

· Expertise in at least one standard (e.g. SDTM, ADaM, TLFs, eSub)

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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.

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 any part of the recruitment process direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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