Senior Biostatistical Programmer

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

Job Summary (Primary function)

The Senior Biostatistical Programmer is responsible for processing clinical data required for the statistical analysis of Phase I – III clinical trials.

Essential Functions of the Job (Key responsibilities)

• Conduct statistical programming work of clinical data using SAS Software.
• Ensure that all programs, outputs and documentation are consistent with ICH guidelines and are conducted in compliance with company SOPs.
• Generate analysis datasets according to CDISC standard and SAP.
• Implement analysis methods according to SAP, and produce summary tables, graphs and data listings using SAS; Conduct adhoc analyses.
• Validate programs and associated results produced by other programming colleagues.
• Participate in TLF shell preparation and review, and assist statistician for SAP preparation.
• Run CDISC validation programs e.g. OpenCDISC reports to ensure ADaM datasets are CDISC compliant.
• Learn, and implement standard SAS macros for efficient analyses of clinical data supervised by Lead programmers.
• Work independently to program for individual studies with minimum supervision.
• Check that the validation summary reports are clean of errors and warnings, and show proper documentation of SAS programs.
• Review individual study CDISC validation output.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• BA/BS degree in mathematics, statistics, computer science or health related field.
• 4 – 8 years of SAS programming working experience in the pharmaceutical industry.
• Good SAS programming skills and attention to details
• Demonstrated knowledge of regulatory guidelines, including electronic submission standards.
• Strong organizational, time management, communication, and project coordination and leadership skills.
• Must be able to work well under timeline pressure.
• Must be able to work on multiple tasks while coordinating others at the same time.

Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws. In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.

By applying to the position, you acknowledge that your information will be used by Kaztronix in processing your application.