Principal Biostatistical Programmer

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

Job Summary (Primary function)

The Principal Biostatistical Programmer is responsible for processing clinical data required for statistical analysis of Phas e I — III clinical trials, leading project teams, and consistently leads of project teams.

Essential Functions of the Job (Key responsibilities)

Function as a Lead programmer for a compound or a group of studies performing the following functions:

• Maintain the overall timeline for his/her studies.
• Maintain the programming standards for his/her studies.
• Review standard macros used; Review standard datasets used.
• Discuss need for programming resources for their group of studies.
• Mentor/Train junior programmers on systems and standards as they work on studies within their area.
• Assist junior programmers in new study set-up to help identify similar studies.
• Review Production area after study programming is complete to make sure datasets, programs, and outputs are properly stored.
• 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.
• Act as a Programming lead for a submission project under supervision of Programming management.
• Serve as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems.

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

• BA/BS degree (MS degree in statistics or computer sciences is desired).
• Minimum 8 years of programming experience using SAS/Base/Macro/GRAPH in the biopharmaceutical and/or CRO industries.
• Data Management experience including CDISC standard is highly desirable.
• Good SAS programming skills and attention to detail are essential.
• Demonstrate 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.
• Demonstrate experience serving as a mentor to junior programmers and as an expert to provide recommendations and solutions to complex problems.

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.