Associate Director, Biostatistics

Location
Princeton, NJ, United States
Posted
Sep 10, 2020
Ref
R1518314
Required Education
Doctorate/PHD/MD
Position Type
Full time
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Purpose

The Biostatistician is a 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
  • Independently leads the development and execution of statistical aspects for multiple complex clinical trials, including contribution to study trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications.
  • Leads portions of filing activities.
  • Utilizes strong technical skills to address complex issues within a team.
  • Assists GBS Lead in addressing regulatory questions and advisory committee preparations.
  • Defends protocols and analysis plans at Protocol Review Committee reviews and provides independent reviews.
  • Participant in continuous improvement initiatives.
  • Demonstrates knowledge outside of traditional statistical expertise in the clinical, regulatory and commercial environments and application within development teams.
  • Effectively engages as a matrix team member on protocol or higher level project teams to act as a scientific and strategic partner in the drug development process.
  • Presents summary data and analyses to key stakeholders and review committees in a clear, concise, complete and transparent manner that provide influence on key development decisions.
  • Extensive technical knowledge of statistical methodology that is appropriately applied 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 relevant experience required.
  • 7+ years Pharmaceutical/R&D or other related experience, including supporting regulatory filings.
  • Experience planning and preparing for regulatory meetings.
  • Expertise in statistical / clinical trials methodology as it relates to clinical development.
  • Capability to solve complex statistical problems.
  • Extensive data analysis planning, execution and delivery experience including co-ordination across multiple protocols.
  • 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.
  • SAS knowledge.


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 the resources to pursue their goals, both at work and in their personal lives.