Bristol Myers Squibb Company

Senior Director Biostatistics

Celgene, NJ, United States
Sep 03, 2020
Required Education
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.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.

Reporting to the VP, Biometrics and Data Operations or to the Executive Director, Biostatistics, this individual will lead the Biostatistics function within and across therapeutic areas of Celgene Corporation. The individual will be responsible for providing statistical input to development strategies, and the formulation of effective implementation plans to support product development objectives in a global organization. The Senior Director will provide expertise and guidance in collaboration with cross-functional groups broadly across the organization in establishing strategy, study design and analyses, and will institute best practices with regard to planning, execution, and interpretation of clinical projects and studies.

Responsibilities will include, but are not limited to, the following:
  • Leads, initiates, and oversees the statistical support for the development of multiple compounds within a therapeutic area in close collaboration with Clinical Development, Regulatory Affairs, Global Drug Safety, Clinical Pharmacology, and Translational Development partners.
  • Provides guidance and management to statisticians to ensure high quality and timely deliverables.
  • Manages resources within a therapeutic area, sets priorities, and ensures consistency and adherence to standards therein.
  • Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses.
  • Contributes to creation/maintenance of, and provides training on statistical topics and departmental SOPs, WPs.
  • Seeks and responds to stakeholder feedback to increase efficiencies, synergies, and performance.
  • Represents Celgene at professional societies, and in industry-wide technical discussions.
  • Is sought after as a trusted employee advocate and management coach by senior management regionally.
  • Resolves technical, quality, and timeline issues.
  • Identifies external statistical experts for consultation.
  • Develops performance metrics for staff.
  • Provides guidance to employees' development plans and carries out performance review and feedback.
  • Manages a functional or project budget, and has authority to allocate company resources according to project needs
  • Proactively builds partnerships with specialist functions and global counterparts to maximize knowledge and available resources.
  • Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities.
  • Ensures that flexible and rapid responses are provided for statistical requests.
  • Anticipates potential issues and take preventive measures.
  • Identifies and assists in the resolution of bottlenecks for study/project teams.
  • Participates in identifying strategies to optimize clinical trial design and in response to regulatory agencies' requests.
  • Represents the company in interfaces with regulatory agencies globally.
  • Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally.
  • Interacts and manages KOLs/CROs and represents the company in external scientific forums.
  • Develops and implements highly innovative solutions to solve complex corporate-wide problems.
  • Provides active coaching to biostatistical team members when developing solutions to problems.
  • Manages team conflicts with external partners/customers.
  • Represents Biostatistics function at high level global project meetings.
  • Act as a resource/mentor to study team members - both internally and externally.
  • Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact.
  • Shapes Biostatistics function, creates and leverages programs, policies, and procedures to provide value added solutions for Biostatistics.
  • Provides input into the long-term Biostatistics strategy and structure.
  • Assesses, provides direction, and resolves complex stakeholder concerns, providing direction to direct reports.
  • Member of BDO Management Staff.
  • Provides Leadership
    • Promotes best practice sharing amongst the broad Statistical and Programming community and focuses on the development of Statisticians/Programmers talent
    • Effectively manages people and encourages them to seek development opportunities
    • Drives functional excellence, collaborates with internal and external partners leading by example and thinking strategically
    • Continually refines and clarifies existing partnerships and relationships by initiating and engaging in projects outside their therapeutic area.
    • Builds a professional and effective Statistical community that is seen as a business asset and attracts, develops and retains top talent

Skills/Knowledge Required:
  • Ph.D. or MS in statistics or related field.
  • Experience in clinical drug development: 11+ years for Ph.D., 13+ years for MS.
  • Demonstrated skill in the planning, analysis and reporting of clinical trials.
  • Detailed knowledge of statistical methodologies and statistical regulatory requirements.
  • Previous direct supervisory experience of statisticians
  • Demonstrated ability to plan, organize, and prioritize multiple work assignments, and strong project management skills.
  • In-depth knowledge of all phases of the global drug development process.
  • Demonstrated ability to work in a team environment with clinical team members.
  • Good interpersonal, communication, writing and organizational skills.
  • Demonstrated skill in resource management.
  • Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards.
  • Abreast of clinical trial development and regulatory requirements for a therapeutic area.
  • Demonstrated development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area.
  • Demonstrated development of resourcing strategies and recruiting practices, working with senior leaders to define positions and organizational structure, and anticipating future requirements and specialty areas.

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.