Associate Director, Biostatistics - Bristol Myers Squibb

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.

Primary 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 GBS 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

Impact:

The Biostatistician is responsible for strategic and scientific contributions at the indication/protocol/integrated analysis level. These contributions lead to better understanding of the asset being studied, improved development decisions, and an increased likelihood of regulatory and market success. This role has significant stakeholder management responsibility with business partners on their team. The biostatistician has responsibility for driving selection of optimal study designs, data collection, analytic approaches and rigorous interpretation of trial data. This person may interact with external vendors, key opinion leaders and regulatory agencies.

Success Factors: Effectively demonstrates fully functioning capability in the following areas:

• Urgency

• Innovation

• Passion

• Inclusion

• Accountability

• Integrity

GBS Leadership Success Factors:

• Leading and Managing Change

• Influence and Impact Relationships

• Decision Making

• Building a Learning Environment

• Emotional Intelligence

• Managing and Developing Performance

Education/Experience:

• Significant academic training in statistics, biostatistics or relevant areas of study. PhD degree in statistics or biostatistics or Master’s degree with relevant experience required.

•  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. 

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.

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 if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please 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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