Lead Statistical Programmer for HIV Trials & AI

GSK; North East; On-site; GBP 65,000 - 105,000; Full time

Job summary

ViiV Healthcare in Durham seeks an experienced Lead Programmer to drive programming for multiple studies, ensuring efficient analysis package development and validation. You will select tools, mentor junior staff, and implement AI/ML improvements while upholding CDISC and regulatory standards.

The role emphasizes collaboration across teams, governance, and TMF compliance, with a focus on HIV drug development and quality-driven workflows in a regulated environment.

Qualifications

• Bachelors degree in Statistics, CS, or related field.
• Expertise in R programming.
• 6+ years of clinical programming experience.
• 5+ years in pharmaceutical/biotech industry.
• Experience with generative AI tools to improve programming.
• Strong experience in HIV clinical trials and drug development.
• Advanced degree in Statistics/CS/Data Science.
• Familiarity with Git-based workflows, reusable frameworks, and automation pipelines.
• Experience with R, Python, and open-source analytics in regulated environments.
• Experience contributing to standards development or digital transformation.
• Knowledge of Agile methodologies and collaborative product development.
• Lead programming activities for complex studies.
• Strong understanding of CDISC standards, regulatory expectations, quality/compliance.
• Excellent analytical, problem-solving, communication, and stakeholder management.
• Experience mentoring junior team members.

Responsibilities

• Lead programming for one or more studies, ensuring development and validation of analysis packages.
• Select appropriate tools and 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 such as GPP and CDISC, including regulatory requirements.
• Perform QC on outputs and technical documents such as cSDRG and 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 an 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 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.

Skills

Statistics

R programming

Git workflows

Python

AI tools

CDISC

Agile

Mentoring

Education

Bachelor's degree in Statistics/CS

Advanced degree in Statistics/CS/Data Science

Tools

Git

GitHub

Copilot

REST

CMS

Python

Job description

ViiV Healthcare in Durham seeks an experienced Lead Programmer to drive programming for multiple studies, ensuring efficient analysis package development and validation. You will select tools, mentor junior staff, and implement AI/ML improvements while upholding CDISC and regulatory standards.

The role emphasizes collaboration across teams, governance, and TMF compliance, with a focus on HIV drug development and quality-driven workflows in a regulated environment.