Lead Biostatistical Programmer - SAS, CDISC, Submissions

Creative Solutions Services, LLC; Wilmington (DE); On-site; USD 110,000 - 170,000; Full time

Job summary

Kaztronix is seeking a Principal Biostatistical Programmer to lead programming efforts across Phase I–III clinical trials. The role emphasizes maintaining timelines, standards, and high-quality outputs, while mentoring junior programmers and guiding complex solutions.

The ideal candidate brings 8+ years of SAS experience, CDISC data management know-how, and strong leadership and communication skills to drive successful regulatory submissions.

Qualifications

• Bachelor-level degree in a quantitative field; MS preferred.
• 8+ years of SAS/Base/Macro/GRAPH programming experience in biopharma/CRO.
• Knowledge of CDISC standards and data management is highly desirable.
• Strong grasp of regulatory guidelines for electronic submissions.
• Demonstrated leadership, planning, and mentoring abilities.

Responsibilities

• Serve as lead programmer for a compound or group of studies.
• Maintain study timelines and programming standards.
• Review macros, datasets, and validation outputs.
• Coordinate allocation of programming resources within studies.
• Mentor junior programmers and provide expert problem-solving guidance.
• Ensure proper storage and documentation of programs and outputs.
• Lead programming efforts for regulatory submissions under management supervision.

Skills

SAS programming

CDISC data management

Regulatory guidelines

Leadership

Time management

Communication

Education

BA/BS in Statistics or Computer Science (MS desired)

Tools

SAS

Job description

Kaztronix is seeking a Principal Biostatistical Programmer to lead programming efforts across Phase I–III clinical trials. The role emphasizes maintaining timelines, standards, and high-quality outputs, while mentoring junior programmers and guiding complex solutions.

The ideal candidate brings 8+ years of SAS experience, CDISC data management know-how, and strong leadership and communication skills to drive successful regulatory submissions.