Principal Statistical Programmer

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

Salary: £65,000 - 105,000 per year

Requirements

• Bachelors degree in Statistics, Computer Science, or a related field.
• Expertise in R programming.
• 6+ years of clinical programming experience.
• 5+ years of experience in the pharmaceutical or biotechnology industry.
• Experience using generative AI tools and coding assistants to improve programming efficiency, automation, code quality, and analytical workflows in clinical programming.
• 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.
• 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 one or more studies, ensuring efficient 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, as well as regulatory requirements.
• Perform QC on critical 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 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.

Technologies

• AI
• Git
• Support
• Python
• CMS
• Copilot
• GitHub
• REST

More

At ViiV Healthcare, our mission is to ensure that the impact of HIV is minimized for individuals and communities worldwide. We are committed to patient focus, transparency, respect, integrity, courage, accountability, development, and teamwork. As part of our 30-year legacy of improving lives with HIV, we are a community where every team member is empowered to bring their very best to the fight against HIV/AIDS. Our holistic approach extends beyond medicine to supporting sustainable community programs and improving access to care. We are the only pharmaceutical company solely focused on combating, preventing, and ultimately eradicating HIV and AIDS, and we combine expertise in research, manufacturing, policy, and more to push the boundaries of what is possible in HIV treatment and care. This full-time role is based in Durham, Blackwell Street, and our employees receive the same benefits options and plans as GSK employees.