Senior Statistical Programmer – Clinical Trials (SDTM/ADaM)

BD; United States; On-site; USD 130,000 - 207,000; Full time

Job summary

BD is seeking a Principal Statistical Programmer to provide hands-on SAS programming for clinical studies, developing and validating analysis datasets and outputs in line with regulatory and company standards.

You will work independently, deliver high‑quality programming deliverables, and collaborate with Biostatistics and Clinical Data Management to ensure inspection‑ready documentation and timely study outputs.

Qualifications

• Bachelor’s degree in Statistics, Mathematics, Computer Science, or related STEM field with 5+ years of statistical programming experience OR Master’s degree with 3+ years of experience
• Demonstrated experience in statistical programming within a clinical trials environment (pharmaceutical/medical device)
• Strong hands‑on experience with SAS programming for clinical trial data (SAS Base, SAS/STAT, SAS Macros)
• Experience with CDISC standards (SDTM/ADaM) and regulatory submissions or CRO/vendor deliverables is a plus
• Excellent written and verbal communication, collaboration, and problem‑solving skills

Responsibilities

• Develop analysis datasets, specifications, and outputs (tables, listings, figures) for clinical study reports and regulatory submissions
• Create, modify, and maintain SAS programs meeting regulatory standards for efficient reporting and traceability
• Perform independent program review and validation with inspection‑ready documentation
• Support ad hoc analyses and collaborate with statisticians and data managers
• Review CRFs, database specifications, and data derivations with cross‑functional teams
• Identify programming risks and communicate issues to study teams

Skills

SAS programming

Statistical programming

Regulatory knowledge (GCP/ICH/FDA/ISO)

CDISC (SDTM/ADaM)

Analytical thinking

SAS macros

Education

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

Master’s degree in related STEM field

Tools

SAS

R

Python

Job description

BD is seeking a Principal Statistical Programmer to provide hands-on SAS programming for clinical studies, developing and validating analysis datasets and outputs in line with regulatory and company standards.

You will work independently, deliver high‑quality programming deliverables, and collaborate with Biostatistics and Clinical Data Management to ensure inspection‑ready documentation and timely study outputs.