Bristol Myers Squibb
pharmaceutical
Director,BiostatisticsHematology
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“Director, Biostatistics Hematology at Bristol Myers Squibb. Skills: Biostatistics, Statistical Analysis, Clinical Trial Design, Drug Development, Regulatory Submissions, Team Leadership. Drives innovative and efficient study design. Develops study designs that address study objectives that will support regulatory approval, medical research and market access”
What You'll Achieve.
Support regulatory approval and market access; Ensure high quality and timely deliverables; Ensure alignment with regulatory agencies and industry standards
Industry & Context.
Solve complex statistical problems; Developing solutions to problems
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, 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
What They're Looking For.
Must Have
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
Nice to Have
at least 3 years management (direct or matrix) experience is preferred (for people manager position only)
What You'll Do.
Drives innovative and efficient study design
Develops study designs that address study objectives that will support regulatory approval
medical research and market access
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
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
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
Manages a functional or project budget
and has authority to allocate company resources according to project needs
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
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
How You'll Work.
Team & Collaboration
member of cross-functional team; Engages as a matrix team member on high level development teams; Acts 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; Contributes to the statistical community of practice
Communication Scope
Excellent communication skills; Presents and defends complex statistical solutions in a clear, concise, complete, and transparent manner; Effectively communicates the GBDS Mission and Vision
Process & Methodology
Manages a functional or project budget, Set priorities, Ensure consistency and adherence to standards
Full Job Description
**Working with Us** Challenging. 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. 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: [careers.bms.com/working-with-us](https://careers.bms.com/working-with-us). At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, cell therapy, immunology, cardiovascular and neuroscience 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 Summary** Director 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 time
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