Senior Biostatistical Programmer — CDISC/SAS Lead

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 120,000 - 140,000; Full time

Job summary

Kaztronix in Delaware seeks a Senior Biostatistical Programmer responsible for processing clinical data for statistical analysis of Phase I–III trials, primarily using SAS. The role ensures CDISC/ADaM compliance and adheres to ICH guidelines while producing analysis datasets and outputs.

You will generate analysis datasets, tables, graphs, and listings, validate programs, and support SAP development under deadlines, collaborating with Lead programmers and statisticians.

Qualifications

• BA/BS in mathematics, statistics, computer science, or health-related field.
• 4–8 years SAS programming experience in pharma.
• Strong SAS skills and attention to detail.
• Knowledge of regulatory guidelines and electronic submissions.

Responsibilities

• Perform statistical programming for clinical data using SAS.
• Ensure compliance with ICH guidelines and SOPs.
• Create analysis datasets per CDISC standard and SAP.
• Produce tables, listings, and graphs; conduct adhoc analyses.
• Validate programs and results produced by team members.
• Assist in SAP preparation and TLF shell work.
• Run CDISC validation programs to ensure ADaM compliance.
• Learn and implement standard SAS macros under supervision.
• Work independently on multiple studies with minimal supervision.
• Check validation summary reports for errors and proper documentation.

Skills

SAS programming

Attention to detail

Regulatory guidelines

Project coordination

Leadership

Education

BA/BS in mathematics, statistics, computer science or health-related field

Tools

OpenCDISC

CDISC Validation

SAS Software

Job description

Kaztronix in Delaware seeks a Senior Biostatistical Programmer responsible for processing clinical data for statistical analysis of Phase I–III trials, primarily using SAS. The role ensures CDISC/ADaM compliance and adheres to ICH guidelines while producing analysis datasets and outputs.

You will generate analysis datasets, tables, graphs, and listings, validate programs, and support SAP development under deadlines, collaborating with Lead programmers and statisticians.