Director, Biostatistics

Company: Disability Solutions
Location: San Diego
Posted on: November 1, 2024

Job Description:

Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.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. Read more: .Position SummaryDirector of Biostatistics is a member of cross-functional team and contributes to development of compounds within a therapeutic area. Drives the design of innovative and efficient clinical trials, including the selection of populations to study and endpoints to use. Develops trial designs that address study objectives that will support regulatory approval and market access. 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. Manages resources, sets priorities, and ensures consistency and adherence to standards therein. Key Responsibilities

• Drives innovative and efficient study design. Develops study designs that address study objectives that will support regulatory approval, medical research and market access.
• Independently leads, initiates, and oversees the statistical support for the development of compounds within a therapeutic area
• Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Effectively engages as a matrix team member on high level development teams, to act as a scientific and strategic partner in the drug development process
• Presents and defends complex statistical solutions to all levels of BMS governance, key stakeholders and external regulatory bodies in a clear, concise, complete, and transparent manner that provide influence on key decisions
• Contributes to Clinical Development Plans, leads GBDS related submission activities, and post-submission strategies/ preparations/defenses.
• Provides statistical support and leadership to address health authority request, publication, presentation, and other public release of information.
• Compliant with BMS processes and SOPs, adherence to global and project standards within an indication or therapeutic area and responsible for quality of deliverable
• Contributes to creation/maintenance of and provide training on statistical topics departmental SOPs.
• Provides guidance and management to statisticians to ensure high quality and timely deliverables.
• Manages a functional or project budget, and has authority to allocate company resources according to project needs, set priorities, and ensure consistency and adherence to standards therein.
• Represents BMS at professional societies, and in industry-wide technical discussions.
• Contributes to the statistical community of practice
• Provides active coaching to biostatistical team members when developing solutions to problems.
• Effectively communicates the GBDS Mission and Vision in a fashion that generates pride, excitement and commitment within GBDS.
• Enables a culture of inclusiveness, respect for diversity, compliance with process and allows for the questioning and challenging of others in a respectful and constructive manner. Applicable to people managers
  • Effectively engages as an employee advocate and management coach/mentor to team members both internally and externally
  • Provides leadership to empower and develop the team.
  • Provides guidance to employee's development plans and carries out performance review and feedback. Develops performance metrics for staff. Qualifications & Experience
    • PhD (9+ years experience) or MS (11+ 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 & simulation.
    • Excellent interpersonal, communication, writing and organizational skills
    • Demonstrate expertise in applying knowledge of general and cutting edge statistical / clinical trials methodology to solve complex statistical problems in the clinical development area and ensure alignment with regulatory agencies and industry standards.
    • Experience in preparing and participating in global regulatory agency interactions
    • Demonstrate excellent collaboration, organizational/ leadership abilities, and interpersonal skills
    • Demonstrate development of approaches to enhance the Workforce Planning and Talent Management strategy of the internal and external talent pools within a therapeutic area.
    • at least 3 years management (direct or matrix) experience is preferred (for people manager position only) If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as Transforming patients' lives through science--- , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site Protocol BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Mission Viejo , Director, Biostatistics, Executive , San Diego, California