Associate Director, Biostatistics

Bristol Myers Squibb

. Serve as lead biostatistician for clinical oncology projects .

Posted 10/28/2026full-timeRemote • United StatesSenior💰 $173,217 - $209,899 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in biostatistics and statistical methodologies for oncology clinical trials, with proficiency in statistical software and a solid understanding of regulatory requirements. Capable of leading multidisciplinary teams and ensuring compliance with global health authority standards.

Highest-signal resume keywords

Biostatistics ExperienceOncology Clinical DevelopmentStatistical Software ProficiencyCDISC Standards KnowledgeRegulatory Compliance Understanding

ATS Keywords

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Hard Skills

Statistical Strategies DevelopmentStudy Design ExecutionBayesian Methods ApplicationStatistical Analysis Plans AuthoringStatistical Outputs InterpretationProtocol Statistical Sections OwnershipData Analysis Solutions ImplementationClinical Trial Statistical MethodsSimulation for Trial DesignTLF Shells Development

Soft Skills

Excellent Interpersonal SkillsStrong Communication Skills

Tools & Technologies

SASREAST

Certifications & Qualifications

Advanced Degree in Statistics or Biostatistics

Industry Keywords

GCPICH GuidelinesGlobal Regulatory RequirementsCDISCSDTMADaMPharmaceutical IndustryBiotech IndustryClinical TrialsRadiopharmaceutical Therapies

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Serve as lead biostatistician for clinical oncology projects
Develop and execute statistical strategies, study designs, and analyses
Provide biostatistical support for interactions with global health authorities, including FDA and EMA
Contribute to briefing documents, agency-question responses, and submission dossiers
Partner with multidisciplinary project teams to align objectives and ensure timely communication
Identify and implement solutions to statistical and data-analysis issues for clinical trials and regulatory submissions
Author and own protocol statistical sections, statistical analysis plans, and TLF shells
Review study-related documents and validate vendor deliverables, including CDISC data specifications and TLF/analysis outputs
Partner with statistical programmers on regulatory requests, DSUR/IB updates, publications, and ad hoc analyses
Participate in sponsor review of ongoing clinical data to ensure integrity and identify efficacy and safety trends
Explore, pilot, and help implement AI-enabled tools and workflows to improve quality control and operational efficiency
Support development of radiopharmaceutical therapies through early-phase dose finding and optimization, registrational trials, and regulatory submissions

Requirements

What you’ll need

Advanced degree in Statistics or Biostatistics (PhD or MS)
6+ years of biostatistics experience in the pharmaceutical/biotech industry for PhD holders, or 8+ years for MS holders
Experience in oncology clinical development
Experience applying Bayesian methods in a clinical development setting
Proficiency in statistical software, including SAS, R, and EAST, including simulation for trial design
Working knowledge of CDISC standards, including SDTM and ADaM
Ability to review and interpret key statistical outputs
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
Excellent interpersonal and communication skills
Ability to function in a highly regulated environment and adhere to RayzeBio guidelines and SOPs
Willingness to travel approximately 10% of the time
Occasional evening and weekend work may be required

Benefits

Comp & perks

Wellbeing support
Retirement and financial protection benefits
Medical, dental, vision, life and disability insurance offerings
Flexible Time Off (FTO) for U.S.-based exempt employees
11 paid company holidays per year
160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees in Puerto Rico
3 optional holidays for non-exempt employees, RayzeBio employees, and employees in Puerto Rico
Paid sick leave, subject to eligibility
Up to two paid volunteer days per year
Summer hours flexibility
Medical, personal, parental, caregiver, bereavement, or military leaves of absence
Annual Global Shutdown between Christmas Day and New Year's Day
Reasonable workplace accommodations/adjustments and ongoing support for people with disabilities
Additional discretionary incentive cash and stock opportunities may be available