Senior Statistical Programmer – Clinical Trials (SAS)

BD; Irvine (CA); On-site; USD 129,600 - 207,400; Full time

Job summary

BD in Irvine, CA is seeking a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies, developing and validating analysis datasets and outputs in line with regulatory and company standards. The role requires independence, collaboration with Biostatistics and CDM, and the ability to deliver inspection-ready programs.

Strong SAS expertise, CDISC SDTM/ADaM, and demonstrated experience in pharmaceutical or medical device settings are essential.

Qualifications

• Bachelor's degree in Statistics, Mathematics, Computer Science, or related STEM field with 5+ years' experience.
• Master's degree with 3+ years' relevant statistical programming experience.
• Experience performing statistical programming in clinical trials (pharma or medical device).

Responsibilities

• Develop complex analysis datasets, tables, listings, and figures for reports and submissions.
• Create, modify, and maintain SAS programs meeting regulatory standards.
• Perform independent program review and ensure inspection-ready documentation.
• Support ad hoc analyses in collaboration with the statistician.
• Partner with CDM and Biostatistics to review CRFs and data derivations.
• Identify programming risks and communicate them to study teams.

Skills

SAS programming

Clinical trials

CDISC (SDTM/ADaM)

Regulatory compliance

Data analysis & reporting

Cross-functional collaboration

Problem-solving

Education

Bachelor’s degree in Statistics, Mathematics, Computer Science, or related STEM

Master’s degree in related STEM field

Tools

SAS Base

SAS/STAT

SAS Macros

R

Python

Job description

BD in Irvine, CA is seeking a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies, developing and validating analysis datasets and outputs in line with regulatory and company standards. The role requires independence, collaboration with Biostatistics and CDM, and the ability to deliver inspection-ready programs.

Strong SAS expertise, CDISC SDTM/ADaM, and demonstrated experience in pharmaceutical or medical device settings are essential.