Statistical Programming Lead, Clinical Data Management, R&D, Orion Corporation

Job Description Statistical Programming Lead will join a growing oncology-focused Data Sciences function and provide strategic and operational leadership for statistical programming activities supporting oncology drug development programs across Phase I–III clinical development. Reporting to the Head of Clinical Development Data Services, this role is responsible for ensuring the timely delivery of high-quality, regulatory-compliant programming deliverables that support clinical development, regulatory submissions, and key business objectives. The Statistical Programming Lead partners closely with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, Medical Writing, and external service providers to drive programming strategy, establish standards, and ensure efficient execution across studies and programs. This role can be based in Cambridge (MA) or in Cambridge, UK. Responsibilities Provide leadership and oversight for statistical programming activities across multiple clinical studies and development programs. Serve as the programming lead for assigned programs and represent Statistical Programming on cross‑functional development teams. Develop and implement programming strategies that support clinical development objectives, regulatory submissions, and operational efficiency. Oversee the development, validation, and delivery of SDTM, ADaM, TLFs, define.xml files, reviewer guides, and other submission‑related deliverables. Ensure programming deliverables are completed with high quality, on schedule, and in compliance with regulatory requirements and company standards. Drive the development, maintenance, and governance of programming standards, tools, templates, and best practices. Act as a subject matter expert on CDISC standards, regulatory submission requirements, and programming methodologies. Collaborate with Biostatistics to ensure efficient implementation of Statistical Analysis Plans and consistency of statistical deliverables. Contribute to submission strategies and support regulatory filings, including NDA, BLA, and MAA submissions. Drive continuous improvement initiatives, automation strategies, and adoption of innovative technologies to improve programming efficiency and quality. Evaluate and promote appropriate use of AI‑assisted development tools, automation frameworks, and modern analytics technologies within the programming environment. Mentor, coach, and develop statistical programmers while fostering technical excellence and professional growth. Qualifications Bachelor's, Master's, or equivalent degree in Statistics, Biostatistics, Computer Science, Mathematics, or a related quantitative discipline. 10+ years of statistical programming experience within the pharmaceutical or biotechnology industry, oncology preferred. Demonstrated experience leading programming activities across multiple clinical development programs. Strong expertise in SAS programming, including Base SAS, Macro programming, SQL, and clinical reporting. Experience with R, Python, or other modern programming languages is desirable. Deep knowledge of CDISC standards, including SDTM, ADaM, define.xml, controlled terminology, and submission requirements. Experience supporting global regulatory submissions and interactions with health authorities. Strong understanding of clinical trial processes, GxP requirements, and industry best practices. Experience implementing automation, standardization, and process improvement initiatives. Interest in emerging technologies and practical applications of AI‑assisted programming and automation tools. Excellent communication, collaboration, leadership, and stakeholder management skills. #J-18808-Ljbffr Orion Pharma