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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior / Principal Statistical Programmer, Clinical Development Data Services, R&D, Orion Corporation - **Company:** Orion Corporation - **Location:** Boston, MA, United States - **Experience:** Expert - **Salary:** $100,000.0 - $180,000.0 - **Contract:** Contract - **Skills:** Artificial Intelligence, Computer Programming, Databases, Data as a Services, Data Cleansing, Data Governance, Python (Programming Language), SAS (Software), SQL Databases, Macros, Information Technology, Data Management, GXP - **Published:** July 12, 2026 - **Apply:** https://www.indeed.com/viewjob?jk=514199797e97b5e7 ## About the Role * 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 programming skills in SAS (base, macro, SQL, STAT, GRAPH); knowledge of R/Python is an advantage. * Solid 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, and documentation skills. ## Description As a Senior / Principal Statistical Programmer in a growing oncology-focused Data Sciences function, you are responsible for the development, validation, and delivery of clinical trial datasets, statistical outputs, and regulatory submission packages that support oncology drug development programs. This role contributes to the successful execution of Phase I-III clinical studies through high-quality programming, data standardization, and submission-ready deliverables in compliance with CDISC standards and applicable regulatory requirements. Responsibilities * Independently lead programming activities of moderate to high complexity while ensuring quality, accuracy, and adherence to timelines. * Develop, validate, and maintain SDTM and ADaM datasets in accordance with CDISC standards, study specifications, and regulatory requirements. * Program, validate, and deliver Tables, Listings, and Figures (TLFs) for clinical study reports, interim analyses, and regulatory submissions. * Perform quality control (QC) reviews and ensure traceability, reproducibility, and compliance of programming deliverables. * Contribute to the development of dataset specifications, define.xml files, reviewer guides, and other submission documentation. * Support preparation and delivery of electronic submission packages for global regulatory agencies, including FDA and EMA. * Collaborate with Biostatisticians on implementation of Statistical Analysis Plans (SAPs) and interpretation of programming requirements. * Support data review, data cleaning, discrepancy management, and database lock activities throughout the study lifecycle. * Work closely with Data Management and external vendors to ensure consistency of standards and data quality. * Ensure compliance with SOPs, GxP requirements, CDISC standards, and industry best practices. * Drive adoption of innovative programming approaches and AI-assisted workflows to improve efficiency, quality, and scalability of clinical trial deliverables. * Contribute to programming standards, macros, and process improvements that enhance efficiency and quality. * Provide technical guidance and mentoring to junior programmers when appropriate. This role can be based in Cambridge (MA) or in Cambridge, UK and reports to Head of Clinical Development Data Services. ## Related Videos - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Crafting Custom Frameworks with Rust: A Deep Dive into Procedural Macros](https://www.wearedevelopers.com/videos/849-crafting-custom-frameworks-with-rust-a-deep-dive-into-procedural-macros) - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [DataForce Studio](https://www.wearedevelopers.com/videos/1657-dataforce-studio) - [Fault Tolerance and Consistency at Scale: Harnessing the Power of Distributed SQL Databases](https://www.wearedevelopers.com/videos/1146-fault-tolerance-and-consistency-at-scale-harnessing-the-power-of-distributed-sql-databases) - [Geometric deep learning for drug discovery](https://www.wearedevelopers.com/videos/264-geometric-deep-learning-for-drug-discovery) ## Related Articles - [Highest Paying Tech Companies for Developers](https://www.wearedevelopers.com/magazine/220-highest-paying-tech-companies-for-developers) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [Coffee with Developers - Maria Apazoglou - Making AI understandable for all in production](https://www.wearedevelopers.com/magazine/475-coffee-with-developers-maria-apazoglou-making-ai-understandable-for-all-in-production) - [10 Highest Paying Programming Languages 2025](https://www.wearedevelopers.com/magazine/150-10-highest-paying-programming-languages-2025) - [Everything a Developer Needs to Know About MCP with Neo4j](https://www.wearedevelopers.com/magazine/604-everything-a-developer-needs-to-know-about-mcp-with-neo4j)