Job Description

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.

* Position Summary

This role is a member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions. With appropriate experience, this position can have responsibilities for integrated summaries and/or supporting a particular indication of an asset. These individuals develop collaborative relationships and work effectively with the GBS Biostatistics Lead, the GBS Planning and Execution Lead, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team. This position is an individual contributor and report to a GBS Lead.

Position Responsibilities

* Develops expertise beyond biostatistics by researching the medical literature and regulatory documents to develop an understanding of the clinical, regulatory and commercial climate.
* Contributes to preparation of the development strategy that will allow for effective and safe utilization of the product.
* Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access.
* Translates scientific questions into statistical terms and statistical concepts into layman terms.
* Challenges collaborator assumptions and positions based on facts and provide insights and perspective based on available information.
* Ensures that all analyses conducted have clearly articulated hypotheses associated with them and that the trial design and data collected support conducting the analysis.
* Communicates effectively with clinical and regulatory partners and external opinion leaders.
* Builds the external reputation of BMS R&D via external interactions through collaborations with alliance partners, academic and government research organizations and through conference participation.
* Authors and/or reviews protocol synopsis, protocol, statistical analysis plan, data presentation plan, case-report forms, clinical study reports, associated publications and other study level specification documents.
* Exercises cost-disciplined science in sizing of the trials and in the planning for the analyses to be conducted.
* Compliant with BMS processes and SOPs, global and project standards, and responsible for quality of deliverables.
* Ensures programming team or vendor partner understands the nature of the clinical data being collected and the approaches to summarizing the information.
* Collaborates with clinicians and medical writers to prepare summaries of results for use in regulatory documents and scientific articles.
* Drives, with the Clinician, the interpretation of results, development of key messages and communication to the development team.
* Drives alignment at team (IPT) level, and escalates lack of team alignment to the GBDS Lead for resolution.
* Provides statistical consultation for ad hoc analysis requests including design of appropriate analyses to answer relevant questions.
* Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
* Keeps up-to-date with state-of-the art applied statistical methodology.
* Degree Requirements

Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Masters degree with relevant experience required.

Experience Requirements

> 3 years Pharmaceutical/R&D or other related experience

Key Competency Requirements

* Understanding of the application of biostatistics to medical/clinical trials data.
* Ability to work successfully within cross-functional teams leading to successful global regulatory filings and approvals.
* Excellent verbal and written communications skills.
* Ability to be flexible and adapt quickly to the changing needs of the organization.
* Ability to organize multiple work assignments and establish priorities.
* Strong interpersonal skills evidenced in interactions with individuals at all levels of the organization, and demonstrated ability to develop relationships within the organization and leverage the formal and informal organizational structure to assist in goal achievement.

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.