Principal Statistical Programmer, Oncology

Salary: £65,000 - 105,000 per year

Requirements:

• Bachelors degree at minimum; a major in computer science, data science, mathematics, or statistics is preferred
• 7+ years of experience as a statistical programmer on a biotech/pharmaceutical clinical development biometrics team or similar team, supporting drug development, medical device development, or intervention studies
• Experience with oncology endpoints and analyses
• Exceptional SAS programming skills and expertise developing and implementing statistical programming procedures and processes in a clinical development environment
• Extensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulations
• Experience supporting regulatory submissions and interacting with the FDA and/or global regulatory authorities
• Ability to work independently
• Outstanding written and verbal communication skills and strong leadership skills
• Preferred: Proficiency in tools or languages beyond SAS, such as R, Python, Java, Shiny, Markdown, Unix/Linux, or Git

Responsibilities:

• Generate SDTM and ADaM specifications and datasets, reviewers guides, and Define.xml files for multiple studies
• Develop SAS programs to generate datasets, complex listings and tables—including descriptive and standard inferential statistics in collaboration with a statistician—and complex graphs
• Develop, validate, and maintain SAS and/or R programs tailored to clinical development program needs
• Oversee CRO statistical programming deliverables across multiple clinical studies to ensure quality and adherence to timelines
• Support preparation of clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analyses
• Follow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelines
• Contribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macros
• Participate in developing CRFs, edit check specifications, and data validation plans
• Review and/or author data transfer specifications for external vendor data
• Collaborate with internal and external functions, including CROs, software vendors, and clinical development partners, to meet project timelines and goals
• Review and/or author SOPs and work instructions related to statistical programming practices

Technologies:

• Embedded
• Support
• Java
• Linux
• Python
• SAS
• Unix
• XML
• Git

More:

We offer a full-time, sponsor-dedicated Principal Statistical Programmer role, embedded with one of our global pharmaceutical clients and supported by Cytel. The position is in our FSP Services business unit and reports to the Director of Biostatistics and Programming. Our client is advancing the next generation of patient treatment and offers an environment emphasizing autonomy and ownership. Cytel provides statistical software and advanced analytics for clinical trial design and execution, and our global, diverse teams bring together expertise in biostatistics, statistical programming, and data management. We support employee success through ongoing training, development, and support, and offer meaningful work and stimulating challenges across clinical development and related fields.

last updated 40 week of 2026