Principal Statistical Programmer

Dormont Manufacturing Co; North Carolina; On-site; USD 85,000 - 115,000; Full time

Job summary

Dormont Manufacturing Co is actively looking for a Principal Statistical Programmer in North Carolina. This role involves leading programming activities for various studies, ensuring high-quality outputs and compliance with regulatory standards. The ideal candidate will have a Bachelor’s degree in Statistics or a related field, along with over six years of clinical programming experience and a deep understanding of statistical programming and regulatory requirements.

This position not only focuses on technical leadership but also emphasizes mentorship to junior programmers and contributions to innovative techniques, including the use of AI tools. Join a team that is committed to excellence in statistical programming.

Qualifications

• Expertise in R programming and 6+ years of clinical programming experience.
• 5+ years of experience in the Pharmaceutical or Biotechnology industry.
• Strong understanding of CDISC standards and regulatory expectations.

Responsibilities

• Lead programming for studies and ensure quality, compliance, and efficient execution.
• Drive adoption of modern technologies and mentor junior programmers.
• Collaborate cross-functionally and manage data access properly.

Skills

R programming

Statistical analysis

Mentorship

Programming efficiency

Agile methodologies

Problem-solving

Education

Bachelor’s degree in Statistics, Computer Science, or a related field

Tools

GitHub Copilot

Python

open-source analytics tools

Job description

We are looking for a Principal Statistical Programmer to lead programming activities for one or more studies, ensuring high-quality development, validation, and delivery of complex analysis outputs. The role drives technical excellence and provides strategic insights into study data while mentoring junior programmers.

Technical Leadership & Delivery

• Lead programming for studies, ensuring efficient development and validation of analysis packages.
• Select appropriate tools/languages and solve complex technical challenges.
• Identify and implement improvements, including use of AI/ML.
• Contribute to departmental initiatives and technical strategy.

Quality & Compliance

• Ensure adherence to standards (e.g., GPP, CDISC) and regulatory requirements.
• Perform QC on critical outputs and technical documents (e.g., cSDRG, ADRG).
• Maintain governance and oversee TMF compliance.

Strategy & Innovation

• Drive adoption of modern technologies, standards, and Agile practices.
• Provide technical input on programming strategies and study design.
• Act as SME for emerging tools when needed.

Communication & Mentorship

• Communicate technical concepts, risks, and timelines clearly to stakeholders.
• Mentor junior programmers and share best practices internally and externally.

Collaboration & Execution

• Support sprint planning and project delivery across studies.
• Collaborate cross-functionally and manage data access appropriately.
• Support regulatory interactions and contribute to CoE activities.

Accountabilities

• Serve as Lead Programmer for complex or multiple studies.
• Ensure quality, compliance, and efficient execution of programming activities.
• Make data-driven decisions and proactively address risks and issues.

Basic Qualification

• Bachelor’s degree in Statistics, Computer Science, or a related field.
• Expertise in R programming.
• 6+ years of clinical programing experience.
• 5+ years of experience in the Pharmaceutical or Biotechnology industry.
• Experience using generative AI tools and coding assistants (e.g., GitHub Copilot, Codex, and Claude) to improve programming efficiency, automation, code quality, and analytical workflows in clinical programming.

Preferred Qualification

• Strong experience supporting HIV clinical trials and drug development within the pharmaceutical or biotechnology industry.
• Advanced degree in Statistics, Computer Science, Data Science, or a related discipline.
• Experience using generative AI tools and coding assistants (e.g., GitHub Copilot, Claude, or Codex) to improve programming productivity and automation.
• Familiarity with modern software engineering practices, including Git-based workflows, reusable frameworks, and automation pipelines.
• Experience with R, Python, and open-source analytics tools within regulated clinical development environments.
• Experience contributing to standards development, process improvement, or digital transformation initiatives.
• Knowledge of Agile delivery methodologies and collaborative product development approaches.
• Demonstrated experience leading programming activities for complex clinical studies or multiple projects.
• Strong understanding of CDISC standards, regulatory expectations, and quality/compliance requirements.
• Excellent analytical, problem-solving, communication, and stakeholder management skills.
• Experience mentoring or guiding junior team members.

ViiV is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.