Director, Biostatistics

Company: Disability Solutions
Location: Princeton
Posted on: October 19, 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: .The GBDS Lead is a core member of the development team. Along with the clinical and regulatory leads, the GBDS Lead is responsible to provide scientific and strategic leadership and has a shared responsibility for developing the clinical/regulatory strategy. Among other things, the GBDS Lead provides strategic input into the design/planning of clinical trials, data analysis approaches, interpretation of findings and crafting of key messages. The GBDS Lead typically represents GBDS in meetings with global regulatory agencies. The GBDS Lead has accountability for the performance of the GBDS team and ensures the team's ability to execute with quality in agreed to timelines. The GBDS Lead may have direct reports and is responsible for coaching and developing all members of their team. GBDS Leads may serve as members of the GBDS Extended Leadership Team and contribute to the continuous improvement of GBDS, which includes but is not limited to recruitment of talent, improving processes, and contributing to the strategic initiatives/directions of GBDS.

• The GBDS lead leads the Quantitative Sub-team and is a core member of an early/late development or medical team and key sub teams. Contributes to all aspects of the development strategy. Partners with the team to prepare a development strategy that will enable the effective and safe utilization of the product.
• Assumes a leadership role within the GBDS organization by contributing and having influence in the development of GBDS capabilities, talent management and sharing of best practices across GBDS. The GBDS Lead serves as a model of scientific and strategic engagement for their team.
• Dependent on experience, scope of the role/team and sphere of influence that the GBDS Lead has, he or she may serve on the GBDS Extended Leadership Team.
• Invests in developing knowledge outside of traditional statistical expertise in the clinical, regulatory, and commercial environments that impact the development team.
• Oversees the selection of trial designs, endpoints, statistical analysis strategy, development of DMC proposals, and contributes to the interpretation of trial results and development of the key messages and their communication.
• Identifies project resource needs, and, in coordination with the development team, aligns team's approved objectives and timelines with the GBDS project level book of work and the allocation of GBDS resources to ensure effective delivery.
• Has accountability for the GBDS team (internal and/or external) to effectively deliver on both scientific accountabilities and operational tasks (e.g. tables, figures, listings), while maintaining compliance with Good Clinical Practices, regulations, global standards, SOPs and established work processes.
• Coordinates the ad hoc analysis process and has decision making authority on acceptance of new analyses.
• Effectively communicates with internal scientific governance bodies, clinical and regulatory partners, and external opinion leaders.
• Manages relationships and interactions with development alliance partners.
• Builds the external reputation of BMS via external interactions (academic relationships, conference presentations, governmental research organization reviewer, etc.).
• Presents or responds to questions at Health Authority meetings.
• Manages the GBDS project team to take advantage of opportunities, overcome obstacles, and achieve program milestones. Facilitates the development of innovative solutions to both broad development issues and statistical issues.
• Contributes to GBDS strategic initiatives through participation on initiative teams and/or contributing to feedback sessions.
• Line/matrix management responsibilities:
  • Effectively manages, develops, evaluates, and retains direct reports, resulting in an increasing level of capabilities for the GBDS organization.
  • 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.
  • Conducts objective setting, mid-year reviews and end of year discussions in compliance with BMS policies. Aligns objectives, feedback, and evaluation of performance with employee's matrix manager, if applicable.
  • Establishes a development plan with each direct report and meet as frequently as required to deliver timely positive/development feedback and coaching.
  • Conducts regular 1 on 1 with each direct report, focused on both project updates and developmental discussions. Periodically checks in with employees between planned discussions.
  • Ensures compliance of direct reports with training requirements and all relevant SOPs.
  • Recommends to and gains alignment of senior managers (GBDS LT) with respect to issues of promotion, performance concerns and retention risks.
  • Differentially recognizes, develops and rewards talent in roles that are critical to BMS and GBDS future growth through leadership opportunities and areas of visibility within and external to GBDS.
  • Contributes to development of a succession plan for critical positions. 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.

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