Senior Statistical Programmer — Clinical Trials & SAS

bdx; Irvine (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

BD, a leading global medical technology company, seeks a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies. You will develop analysis datasets, specifications, tables, listings, and figures, and create, modify, and maintain SAS programs meeting regulatory standards.

You will validate outputs, ensure traceability, support planned analyses with statisticians, review CRFs and data derivations with CDM and Biostatistics, and communicate risks

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or related field; 5+ years of statistical programming experience OR
• Master’s degree in related STEM field with 3+ years of experience; clinical trials programming experience preferred.
• Experience with SAS programming for clinical trial data and regulatory submissions.

Responsibilities

• Develop analysis datasets, specifications, and outputs (tables/listings/figures) for clinical study reports and regulatory submissions.
• Create/modify SAS programs meeting regulatory standards for data management and reporting.
• Perform independent program validation and maintain compliant documentation.
• Support planned analyses and respond to data review questions with statisticians.
• Collaborate with Clinical Data Management and Biostatistics on CRFs, database specs, and data derivations.
• Identify programming risks and data issues and communicate them to the study team.

Skills

SAS programming

SAS Base

SAS/STAT

SAS Macros

CDISC SDTM

CDISC ADaM

Regulatory knowledge

GCP/ICH/FDA

R or Python

Data reporting

Education

Bachelor's in Statistics/related STEM

Master's in related STEM

Tools

SAS Base

SAS/STAT

SAS Macros

Excel

PowerPoint

Job description

BD, a leading global medical technology company, seeks a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies. You will develop analysis datasets, specifications, tables, listings, and figures, and create, modify, and maintain SAS programs meeting regulatory standards.

You will validate outputs, ensure traceability, support planned analyses with statisticians, review CRFs and data derivations with CDM and Biostatistics, and communicate risks