Director, Biostatistical Programming — Oncology

Bristol Myers Squibb; San Diego (CA); On-site; USD 227,000 - 276,000; Full time

Benefits offered by this job

Health Coverage

401(k) plan

Wellbeing Support

Job summary

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Director of Biostatistical Programming to lead clinical study deliverables, vendor oversight, and cross-functional data reviews in oncology. The role focuses on SAS programming, regulatory compliance (CDISC standards), and infrastructure development within a fast-paced team.

The candidate will manage CRO relationships, drive SOPs, and contribute to CSRs and regulatory submissions while supporting AI-enabled process

Qualifications

• Bachelor's or higher in statistics/mathematics or related field.
• Experience with pharmaceutical industry preferred.
• Oncology/clinical trial experience advantageous.

Responsibilities

• Oversee vendors' activities and review deliverables for quality.
• Review and report clinical trial data for DSUR/IBs and FDA briefing documents.
• Collaborate with cross-functional teams to review study documents and data.
• Oversee CDISC data packages for CSRs and regulatory submissions.
• Develop and maintain SAS programming infrastructure and SOPs.

Skills

SAS programming

Statistical reporting

CDISC SDTM/ADaM

Regulatory knowledge FDA/ICH

Cross-functional collaboration

Data review

Education

Bachelor's degree in statistics or mathematics

Master's degree in statistics or computer science

Tools

SAS

Job description

RayzeBio, a wholly-owned subsidiary of Bristol Myers Squibb, seeks a Director of Biostatistical Programming to lead clinical study deliverables, vendor oversight, and cross-functional data reviews in oncology. The role focuses on SAS programming, regulatory compliance (CDISC standards), and infrastructure development within a fast-paced team.

The candidate will manage CRO relationships, drive SOPs, and contribute to CSRs and regulatory submissions while supporting AI-enabled process