Director, Biostatistical Programming
Bristol Myers Squibb
July 01, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
Job Responsibilities:
- Oversee vendors’ activities and review vendors’ deliverables to ensure quality.
- Review, analyze, and report clinical trial data; generate outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests.
- Collaborate with cross-functional teams to review critical study documents and perform data reviews for ongoing studies.
- Oversee CDISC data package development to support CSRs and future regulatory submissions.
- Establish programming and QC processes and create related SOPs (with support from Head of Biostatistical Programming).
- Develop and maintain SAS programming infrastructure and processes to ensure quality and compliance.
- Create SAS macros/applications to streamline processes and enhance efficiency.
- Leverages AI to drive program/portfolio/functional performance through prioritization and scaled adoption.
Qualifications (Education & Experience):
- Bachelor’s degree in statistics, mathematics, or equivalent with at least 15 years’ pharma industry experience; or master’s degree in statistics or computer science with at least 12 years’ programming experience (preferred).
- Oncology therapeutic area experience required.
- Proven ability to manage CRO relationships and oversee programmed deliverables.
- Advanced SAS programming and statistical reporting skills.
- In-depth CDISC knowledge (SDTM, ADaM) and FDA electronic data submission requirements.
- Advanced knowledge of FDA and ICH regulations/guidelines and clinical trial methodologies.
- Good written and verbal communication skills.
- Ability to work productively in a fast-paced collaborative environment.
- Travel ~10%; evening/weekend work involved.
- Oversee vendors’ activities and review vendors’ deliverables to ensure quality.
- Review, analyze, and report clinical trial data; generate outputs to support DSUR/IBs, publications, FDA meeting briefing documents, and other internal ad-hoc requests.
- Collaborate with cross-functional teams to review critical study documents and perform data reviews for ongoing studies.
- Oversee CDISC data package development to support CSRs and future regulatory submissions.
- Establish programming and QC processes and create related SOPs (with support from Head of Biostatistical Programming).
- Develop and maintain SAS programming infrastructure and processes to ensure quality and compliance.
- Create SAS macros/applications to streamline processes and enhance efficiency.
- Leverages AI to drive program/portfolio/functional performance through prioritization and scaled adoption.
Qualifications (Education & Experience):
- Bachelor’s degree in statistics, mathematics, or equivalent with at least 15 years’ pharma industry experience; or master’s degree in statistics or computer science with at least 12 years’ programming experience (preferred).
- Oncology therapeutic area experience required.
- Proven ability to manage CRO relationships and oversee programmed deliverables.
- Advanced SAS programming and statistical reporting skills.
- In-depth CDISC knowledge (SDTM, ADaM) and FDA electronic data submission requirements.
- Advanced knowledge of FDA and ICH regulations/guidelines and clinical trial methodologies.
- Good written and verbal communication skills.
- Ability to work productively in a fast-paced collaborative environment.
- Travel ~10%; evening/weekend work involved.