Senior Director, Biostatistical Programming

Bristol Myers Squibb EU Policy

San Diego (CA)

On-site

USD 227,000 - 276,000

Full time

2 days ago
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Job summary

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, is seeking a Director of Biostatistical Programming in San Diego. The role leads programming deliverables, oversees CRO vendors, and collaborates with cross‑functional teams to ensure high‑quality data outputs for regulatory submissions and publications.

The candidate will drive SAS programming strategies, CDISC standards, and regulatory compliance, while advancing automation and AI‑driven efficiency.

Qualifications

  • Bachelor's degree in statistics or mathematics or equivalent with 15+ years in pharma, or Master's with 12+ years programming experience.
  • Oncology therapeutic experience required.
  • Proven ability to manage CRO relationships and oversee programmed deliverables.
  • Advanced knowledge of SAS programming and statistical reporting.

Responsibilities

  • Oversee vendors' activities and review deliverables for quality.
  • Review, analyze, and report clinical trial data and outputs for DSUR/IBs, publications, FDA briefing docs.
  • Collaborate with cross-functional teams to review study documents and perform data reviews.
  • Oversee CDISC data package development to support CSRs and regulatory submissions.
  • Assist head of Biostatistical Programming in establishing programming and QC processes; create SOPs.
  • Develop and maintain SAS programming infrastructure and processes for quality and compliance.
  • Create SAS macros/applications to streamline processes and enhance efficiency.
  • Leverage AI to drive program, portfolio, or functional performance through prioritization.

Skills

SAS programming
Statistical reporting
CDISC (SDTM/ADaM)
Regulatory knowledge (FDA/ICH)
Communication
Vendor management

Education

Bachelor's degree in statistics or mathematics
Master's degree in statistics or computer science

Tools

SAS
SAS macros

Job description

RayzeBio, a wholly owned subsidiary of Bristol Myers Squibb, is seeking a Director of Biostatistical Programming in San Diego. The role leads programming deliverables, oversees CRO vendors, and collaborates with cross‑functional teams to ensure high‑quality data outputs for regulatory submissions and publications.

The candidate will drive SAS programming strategies, CDISC standards, and regulatory compliance, while advancing automation and AI‑driven efficiency.

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