Associate Director, Biostatistics

BMS; Lawrence Township (NJ); Remote; USD 173,000 - 210,000; Full time

Benefits offered by this job

Flexible Time Off

11 paid company holidays

Comprehensive benefits

Job summary

RayzeBio, a wholly-owned RayzeBio subsidiary of Bristol Myers Squibb, seeks an Associate Director of Biostatistics to guide design, analysis, and interpretation of clinical trial statistics. You will lead statistical strategy across development phases, from early dose finding to registrational trials, interfacing with global regulators and cross-functional teams.

You will supervise statisticians, review CDISC standards, and drive innovation with AI-enabled workflows to improve quality and

Qualifications

• Advanced degree in Statistics or Biostatistics (PhD or MS).
• 6+ years (PhD) or 8+ years (MS) biostatistics experience in pharma/biotech.
• Experience in oncology clinical development.

Responsibilities

• Lead biostatistician for oncology projects; design strategies and analyses.
• Provide biostatistical support in interactions with global health authorities (FDA/EMA).
• Collaborate with project teams to align objectives and timelines.
• Prepare protocol statistics sections, SAPs, and TLF shells.
• Review vendor deliverables and ensure data quality and regulatory compliance.
• Support regulatory requests, DSUR/IB updates, publications, and ad-hoc analyses.
• Participate in sponsor reviews of ongoing data to identify trends.

Skills

SAS

R

EAST

CDISC SDTM/ADaM

Biostatistics leadership

Education

PhD in Statistics/Biostatistics

Tools

SAS

R

EAST

CDISC SDTM/ADaM

Job description

Life at BMS

At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/

Summary

The Associate Director of Biostatistics at RayzeBio will play a crucial role in guiding the design, execution, and interpretation of statistical analyses for clinical trials, with the overarching goal of facilitating the successful development of innovative radiopharmaceutical therapies. This position combines deep statistical expertise with strategic, hands-on leadership across all phases of clinical development, from early-phase dose finding and optimization through registrational trials and regulatory submissions.

Job Responsibilities

• Serve as the lead biostatistician for clinical oncology projects, developing and executing statistical strategies, study designs, and analyses.
• Provide biostatistical support in interactions with global health authorities (e.g., FDA, EMA), including contributing to briefing documents, responses to agency questions, and submission dossiers.
• Partner closely with multidisciplinary project teams to ensure timely communication and alignment of objectives.
• Identify and implement solutions to statistical and data analysis issues related to clinical trials and regulatory submissions.
• Author and own key statistical documents and outputs, including protocol statistical sections, SAPs, and TLF shells.
• Review study-related documents and review/validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs.
• Partner with statistical programmers to support regulatory requests, DSUR/IB updates, publications, and ad-hoc analyses as needed.
• Participate in the sponsor review of ongoing clinical data to ensure data integrity and identify emerging efficacy and safety trends.
• Explore, pilot, and help implement AI-enabled tools and workflows that enhance quality control and operational efficiency.
• Willing to travel approximately 10% of the time. Occasional evening and weekend work may be required.

Skills and Knowledge

• Excellent interpersonal and communication skills, with the ability to influence cross-functional stakeholders.
• Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and SOPs.
• Proficiency in statistical software (e.g., SAS, R, EAST, including simulation for trial design) and working knowledge of CDISC standards (SDTM/ADaM), with the ability to review and interpret key statistical outputs.
• Demonstrated ability to oversee vendors and ensure the quality, timeliness, and compliance of biometrics deliverables.
• Solid understanding of GCP, ICH guidelines, and global regulatory requirements.
• In-depth knowledge of statistical methods for oncology trials.

Basic Requirements

• Advanced degree in Statistics or Biostatistics (PhD or MS)
• 6+ years (PhD) or 8+ years (MS) of biostatistics experience in the pharmaceutical/biotech industry
• Experience in oncology clinical development
• Experience applying Bayesian methods in a clinical development setting

Preferred Requirements

• Prior experience in radiopharmaceutical therapy (RPT) or imaging (RPI) drug development
• Prior experience with global regulatory submissions
• Prior experience with innovative clinical trial designs (e.g., adaptive designs)
• Prior experience utilizing AI-enabled tools to improve productivity and work efficiency

Physical demands

• While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.

Work Environment

• The noise level in the work environment is usually moderate.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Compensation Overview:

Remote - United States - US: $173,217 - $209,899

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

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are 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 and RayzeBio 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.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607780 : Associate Director, Biostatistics