Lead Clinical Statistical Programmer — Datasets & Reports

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

Job summary

BD's Irvine, California site is seeking a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies, including development and validation of analysis datasets and outputs in line with regulatory and company standards.

You will work independently, deliver high-quality programs, validate and document work for regulatory compliance, and collaborate with Biostatistics and Clinical Data Management to ensure inspection-ready deliverables.

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or a related field with 5+ years of relevant statistical programming experience or Master’s degree with 3+ years of relevant experience.
• Experience performing statistical programming in a clinical trials environment (pharmaceutical and/or medical device).
• Proficiency with SAS programming for clinical trial data (SAS Base, SAS/STAT, SAS Macros).

Responsibilities

• Develop complex analysis datasets, specifications, and outputs for clinical study reports, regulatory submissions, and internal presentations.
• Create, modify, and maintain SAS programs to ensure regulatory compliance and traceability.
• Perform independent program review and validation with inspection-ready documentation.
• Support ad hoc and planned analyses in collaboration with the designated statistician.
• Review CRFs, database specifications, and data derivations with Clinical Data Management and Biostatistics.

Skills

SAS programming

Data analysis

Statistical programming in clinical

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in Statistics/Math/CS or related STEM field

Master’s degree in related STEM field

Tools

SAS Base

SAS/STAT

SAS Macros

CDISC SDTM

CDISC ADaM

Excel

Job description

BD's Irvine, California site is seeking a Principal Statistical Programmer to provide hands-on statistical programming support for clinical studies, including development and validation of analysis datasets and outputs in line with regulatory and company standards.

You will work independently, deliver high-quality programs, validate and document work for regulatory compliance, and collaborate with Biostatistics and Clinical Data Management to ensure inspection-ready deliverables.