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Principal Statistical Programmer

GSK
July 02, 2026
Remote friendly (Durham, NC)
United States
Clinical Research and Development
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.

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

Preferred Qualifications
- Experience supporting HIV clinical trials/drug development.
- Advanced degree.
- Additional generative AI/coding assistant experience.
- Familiarity with Git-based workflows, reusable frameworks, and automation pipelines.
- Experience with R, Python, and open-source analytics in regulated environments.
- Experience in standards development/process improvement/digital transformation.
- Knowledge of Agile methodologies.
- Experience leading programming for complex/multiple projects.
- Strong CDISC and regulatory/quality compliance knowledge.
- Excellent analytical, problem-solving, communication, stakeholder management skills.
- Experience mentoring junior team members.