Senior / Principal Statistical Programmer, Clinical Development Data Services, R&D, Orion Corpo[...]

As a Senior Statistical Programmer in a growing Data Sciences function, you are responsible for developing, validating, and delivering clinical trial datasets, statistical outputs, and regulatory submission deliverables that support oncology drug development programs. This role contributes to the execution of Phase I–III clinical studies through hands‑on programming, data standardization, quality control, and submission‑ready deliverables in compliance with CDISC standards and applicable regulatory requirements. Responsibilities Independently lead and execute statistical programming activities of moderate to high complexity while ensuring quality, accuracy, and adherence to timelines. Lead and contribute to the design, development, validation, QC, and delivery of ADaM datasets, tables, figures, listings, define.xml files, reviewer guides, and other analysis and submission‑related programming deliverables. Support the preparation of submission‑related programming deliverables and regulatory filing packages for global regulatory authorities, including FDA, EMA, and other health authorities, as applicable. Support the development of programming deliverables for scientific publications, abstracts, posters, presentations, and other external scientific communications. Collaborate with Biostatistics to implement Statistical Analysis Plans, mock TLFs, and study reporting requirements into consistent programming deliverables. Support data review, data cleaning, discrepancy management, and database lock activities throughout the study lifecycle. Work closely with Data Management and external vendors to review data transfers, resolve data issues, and support consistency of standards and data quality. Contribute to programming standards, macros, reusable tools, and process improvements that enhance efficiency, consistency, and quality. Apply automation and AI‑assisted programming workflows, where appropriate, to improve efficiency, quality control, traceability, and scalability of clinical trial deliverables. Provide technical guidance and mentoring to junior programmers when appropriate. Qualifications Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative field. 5+ years of statistical programming experience within the pharmaceutical or biotechnology industry, oncology preferred. Strong hands‑on SAS programming expertise, including Base SAS, Macro programming, SQL, and development of analysis datasets and reporting outputs for clinical trials. Knowledge of R and/or Python is an advantage. Strong understanding of CDISC standards, controlled terminology, define.xml, and submission requirements. Hands‑on experience preparing regulatory submission packages (define.xml, Pinnacle 21, reviewer guides) for FDA/EMA. Demonstrated interest in applying automation and AI‑enabled solutions to improve programming efficiency and data quality. Strong attention to detail with excellent analytical, problem‑solving, documentation, and cross‑functional collaboration skills. Location: Cambridge (MA) or Cambridge, UK. Reports to Head of Clinical Development Data Services. #J-18808-Ljbffr Orion Pharma