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.
Purpose
The Associate Director, Biostatistics is a core member of cross-functional development teams and contributes to trial design, protocol development, analysis planning, interpretation of results, preparation of regulatory submissions and publications. Statisticians develop collaborative relationships and work effectively with the Global Biometric Sciences (GBS) Lead, the GBS Planning and Execution Lead, statistical programmers, external partners, medical monitor, protocol manager, data manager, PK scientist, and other members of the study/indication team.
Primary Responsibilities
Core member of an EDT and key sub-teams. Contributes to all aspects of the development strategy.
Independently leads the development and execution of statistical aspects for one or more clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.
Participates in development strategy, protocols and analysis plans reviews.
Participates in continuous improvement initiatives.
Invests in knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments that impact the development teams.
Engages as a matrix team member on protocol teams as a scientific partner in the drug development process.
Ability to present summary data and analyses to key stakeholders in a clear, concise, complete and transparent manner.
Possesses technical knowledge of statistical methodology and ability to appropriately apply it in trial design and data analysis for clear, concise, high-quality results.
Takes accountability for ensuring quality in all planning, design and execution of assignments associated with the assigned protocol or project.
Education/Experience
PhD degree in Statistics or Biostatistics or Master's degree with 7+ years' of relevantPharmaceutical/R&Dor other related experience, including supporting regulatory filings.
Demonstrated knowledge of statistical / clinical trials methodology as it relates to clinical development.
Relevant prior data analysis planning, execution and delivery experience.
Excellent verbal and written communications skills.
Ability to be flexible and adapt quickly to the changing needs of the organization.
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, including the resolution of conflicts or their appropriate escalation
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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