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Director, Biostatistics, San Diego, California

CategoryClinical Dev
Job typeFull-Time
CountryUnited States
CitySan Diego

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.

Position: Director, Biostatistics

Reports to: Sr. Director, Biostatistics

Direct Reports : Yes

Location: San Diego, CA or Berkeley Heights, NJ

General Summary:

The Dir. TA Biostatistician initiates and oversees the statistical support for the development of a single compound or multiple compounds within a therapeutic area in close collaboration with Clinical Development, Regulatory Affairs, Global Drug Safety, Clinical Pharmacology, and Translational Development partners. Contributes to Clinical Development Plans, submissions, and post-submission strategies, preparations and defenses. Provides guidance and management to statisticians to ensure high quality and timely deliverables. Serves as the statistical representative in the defense of the company position/approach on statistical issues and drug approvals globally.

Responsibilities and Duties:

  • Contributes to creation/maintenance of, and provides training on statistical topics, and departmental SOPs, WPs;

  • Shapes the Biostatistics function, creates and leverages programs, policies, and procedures to provide value added solutions for Biostatistics;

  • 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;

  • 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;

  • Advises and influences senior leadership/functional leads on Biostatistics strategies as well as functional issues that have a business impact;

  • Manages and coordinates limited resources to produce quality deliverables within timelines for competing priorities;

  • Acts as a resource/mentor to study team members - both internally and externally;

  • Assesses, provides direction, and resolves complex stakeholder concerns, providing direction to direct reports. Represents Biostatistics function at high level global project meetings;

  • Anticipates potential issues and take preventive measures;

  • Identifies and assists in the resolution of bottlenecks for study/project; teams

  • Builds a professional and effective Statistical community that is seen as a business asset and attracts, develops and retains top talent;

    Knowledge, Skills, Abilities and Qualification Requirements:

  • Ph.D. in statistics, biostatistics, mathematics, or related field;

  • 11+ years of prior experience in a drug-development environment;

  • Strong knowledge of clinical trial design concepts, drug regulation, and experience in the management of the statistical functional;

  • Ability to research new statistical methods and ensure alignment with regulatory agencies and industry standards;

  • Advanced applicational use with SAS and/ or other relevant statistical software to support optimal planning and analysis of clinical trials/ development programs;

  • Keeping abreast of regulatory guidance for relevant indications within a TA

  • 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 ability to work in a team environment with clinical team members with good interpersonal, communication, writing and organizational skills;

  • 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;

  • Experience with managing direct reports and contract personnel;

  • Experience in writing technical documents, reports, and presentations;

  • Excellent computer skills in the following programs: MS Word, PowerPoint, and Excel;

    Key Managerial Attributes:

  • Professionalism and behavior focused;

  • Dedication to integrity, rigor, and transparency;

  • Communication skills - written and verbal;

  • Planning, organizing and multi-tasking;

  • Prioritizing and time management;

  • Problem assessment and problem solving;

  • Information gathering and information monitoring;

  • Attention to detail and accuracy;

    Flexibility, adaptability and teamwork

    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.
  • EmployerBristol-Myers Squibb

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