Senior Statistical Programmer – Clinical Trials

BD; Irvine (CA); On-site; USD 130,000 - 207,000; Full time

Job summary

BD in Irvine, CA seeks a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies. You will develop and validate analysis datasets and outputs in line with regulatory standards.

The role requires delivering high-quality programming deliverables, collaborating with Biostatistics and CDM, and ensuring inspection-ready documentation across CRFs, specs, and data derivations.

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field with 5+ years in statistical programming OR Master’s +3+ years in the field.
• Demonstrated experience performing statistical programming in a clinical trials environment (pharma/med device).
• Strong hands-on SAS programming for clinical trial data (SAS Base, SAS/STAT, SAS Macros).
• Experience with CDISC SDTM/ADaM standards and regulatory submissions.
• Proficiency interfacing SAS outputs with Excel/Word/PowerPoint.

Responsibilities

• Develop analysis datasets, specifications, and outputs (tables, listings, figures) for clinical reports and regulatory submissions.
• Create, modify, and maintain SAS programs meeting regulatory standards and traceability.
• Perform independent program review and validation with inspection-ready documentation.
• Support ad hoc analyses in collaboration with the statistician and data management teams.
• Review CRFs, database specs, edit checks, and data derivations with cross-functional teams.
• Identify programming risks and communicate findings to study team.

Skills

Clinical trials statistics

Regulatory requirements

Data management collaboration

Analytical problem solving

Communication skills

Education

Bachelor’s degree in Statistics/Math/CS

Master’s degree in related STEM field

Tools

SAS Base

SAS/STAT

SAS Macros

CDISC SDTM

CDISC ADaM

Excel

Word

PowerPoint

Job description

BD in Irvine, CA seeks a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies. You will develop and validate analysis datasets and outputs in line with regulatory standards.

The role requires delivering high-quality programming deliverables, collaborating with Biostatistics and CDM, and ensuring inspection-ready documentation across CRFs, specs, and data derivations.