Associate Director, Biostatistics Lead

7 hours ago

San Diego, California, United States Web-atrio Full time
Job Description

At Bristol Myers Squibb, we're passionate about making an impact on the lives of patients with serious diseases. As an Associate Director of Biostatistics, you'll be part of a cross-functional Development team, contributing to trial design, protocol development, analysis planning, interpretation of results, and preparation of regulatory submissions.

Key Responsibilities
  • Collaborate in the design of innovative and efficient clinical trials, including the selection of study population/endpoints to address study objectives, and contribute to project development strategy
  • Defend protocols and analysis plans at internal governance reviews and provide independent reviews of complex protocols
  • Independently author and/or review protocol, statistical analysis plan, clinical study reports, associated publications, and other study level documents
  • Present summary data and analyses results, in a clear, concise, complete, and transparent manner
  • Provide statistical support and leadership to address health authority requests, publication, presentation, and other public release of information
  • Manage multiple studies to ensure consistency and adherence to standards within an indication or therapeutic area
  • Apply extensive knowledge of statistical/clinical trials methodology as it relates to clinical development
Qualifications and Experience
  • PhD (6+ years' experience) or MS (8+ years' experience) in statistics or biostatistics or related scientific field with clinical trials, drug development, pharmaceutical industry, or healthcare experience
  • Proficiency in scientific computing/programming (SAS, R, or Python) and implementation of advanced statistical analysis, data manipulation, graphing, and simulation
  • Great interpersonal, communication, writing, and organizational skills
  • Expertise in statistical/clinical trials methodology as it relates to clinical development and ability to apply to relevant clinical development framework
  • Good understanding of regulatory landscape and experience with participating in regulatory interactions

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.

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