Principal Statistical Programmer

GSK•Durham, CA

About The Position

The Principal Statistical Programmer will lead programming activities for one or more studies, ensuring high-quality development, validation, and delivery of complex analysis outputs. Drive technical excellence, innovation, and standards adoption while providing strategic insights into study data. Mentor junior programmers and influence programming approaches through strong technical leadership and communication. This role will provide YOU the opportunity to lead key activities to progress YOUR career.

Requirements

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.

Nice To Haves

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

Responsibilities

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.
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.
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.
Communicate technical concepts, risks, and timelines clearly to stakeholders.
Mentor junior programmers and share best practices internally and externally.
Support sprint planning and project delivery across studies.
Collaborate cross-functionally and manage data access appropriately.
Support regulatory interactions and contribute to CoE activities.
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.