Director, Biostatistics

Bristol Myers Squibb; Madison (NJ); On-site; USD 219,000 - 265,000; Full time

Benefits offered by this job

Comprehensive benefits

Flexible time off

Job summary

Bristol Myers Squibb seeks a Director of Biostatistics to lead statistical strategy across therapeutic areas, driving innovative trial designs and regulatory submissions. The role partners with cross-functional teams to ensure evidence-based decisions and timely delivery.

You will mentor statisticians, manage resources and budgets, and represent the function in governance meetings and industry collaborations. A PhD or equivalent with extensive trial experience and SAS/R/Python skills is required.

Qualifications

• PhD or MS with extensive clinical trials/biostatistics experience.
• Proficiency in SAS, R or Python.
• Strong writing, presentation and collaboration skills.
• Experience with global regulatory interactions.
• Leadership experience managing statisticians.

Responsibilities

• Design innovative and efficient clinical trial studies to support regulatory approval and market access.
• Lead statistical support for development programs and provide guidance to statisticians.
• Present complex statistical solutions to governance bodies and regulators clearly.
• Collaborate as a scientific partner in drug development within a cross-functional team.
• Contribute to Clinical Development Plans, submissions, and post-submission activities.

Skills

Biostatistics expertise

SAS/R/Python

Regulatory interactions

Leadership/mentoring

Clinical trials knowledge

Statistical programming

Education

PhD in statistics/biostatistics

MS in statistics

Tools

SAS

R

Python

Job description

At Bristol Myers Squibb, our employees often ask, "Who are you working for?"-a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

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 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 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.
• 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 o
• f 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)

Compensation Overview

Cambridge Crossing: $244,990 - $296,867 Madison - Giralda - NJ - US: $218,740 - $265,060 Princeton - NJ - US: $218,740 - $265,060

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits

• Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
• U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
• Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
• Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
• U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

How We Work

Where you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People With Disabilities

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 [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: 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: https://careers.bms.com/california-residents/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

R1607151 : Director, Biostatistics