About this role
Salary: £65,000 - 105,000 per year
Requirements: Bachelors degree at minimum; a major in computer science, data science, mathematics, or statistics is preferred7+ 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 studiesExperience with oncology endpoints and analysesExceptional SAS programming skills and expertise developing and implementing statistical programming procedures and processes in a clinical development environmentExtensive applied experience with CDISC standards (SDTM, ADaM, and Define.xml), medical terminology, clinical trial methodologies, and FDA/ICH regulationsExperience supporting regulatory submissions and interacting with the FDA and/or global regulatory authoritiesAbility to work independentlyOutstanding written and verbal communication skills and strong leadership skillsPreferred: 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 studiesDevelop SAS programs to generate datasets, complex listings and tables—including descriptive and standard inferential statistics in collaboration with a statistician—and complex graphsDevelop, validate, and maintain SAS and/or R programs tailored to clinical development program needsOversee CRO statistical programming deliverables across multiple clinical studies to ensure quality and adherence to timelinesSupport preparation of clinical study reports, regulatory submissions, publications, annual DSURs, and exploratory analysesFollow FDA regulations affecting clinical trial data reporting, including good clinical practice and electronic submission guidelinesContribute to the creation, maintenance, documentation, and validation of standards for programming tools, outputs, and macrosParticipate in developing CRFs, edit check specifications, and data validation plansReview and/or author data transfer specifications for external vendor dataCollaborate with internal and external functions, including CROs, software vendors, and clinical development partners, to meet project timelines and goalsReview and/or author SOPs and work instructions related to statistical programming practices Technologies: EmbeddedSupportJavaLinuxPythonSASUnixXMLGit 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