Principal Biostatistical Programmer

Creative Solutions Services, LLC; Woodbridge Township (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Kaztronix in New Jersey is seeking a Principal Biostatistical Programmer to lead programming efforts for Phase I–III trials, managing data processing and delivering high-quality datasets and analysis outputs for regulatory submissions.

You will mentor junior programmers, maintain study standards and timelines, ensure CDISC validation, and collaborate with cross‑functional teams under time pressure to meet project goals.

Qualifications

• BA/BS degree required; MS in statistics or CS is desirable.
• Minimum 8 years of SAS/Base/Macro/GRAPH programming in biopharma/CRO.
• Data Management experience with CDISC standards is highly desirable.
• Strong organizational, time management, communication and leadership skills.
• Ability to mentor junior programmers and lead complex problem solving.

Responsibilities

• Lead programming for a compound or group of studies and manage timelines.
• Maintain programming standards and review datasets and macros.
• Assess resource needs and coordinate with study teams.
• Mentor/train junior programmers on systems and standards.
• Ensure proper storage of datasets, programs, and outputs and validate reports.
• Lead submission projects under supervision and provide expert recommendations.

Skills

Mentor/Lead programming teams

Regulatory guidelines knowledge

Time management

Communication skills

Project coordination

Education

BA/BS degree

MS degree in statistics or computer sciences

Tools

SAS/Base/Macro/GRAPH

CDISC

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.