Senior / Principal Statistical Programmer, Clinical Development Data Services, R&D, Orion Corporation

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. What you can expect from us At Orion Pharma, your work impacts millions of lives around the world. With us, you get to work on challenges that matter and see the difference your work makes every day. We believe our people are the key to our success, which is why we invest in your continuous learning. Our innovative products are world-class, and we take sustainability and ethics seriously. Rooted in our Nordic heritage, we value teamwork, low hierarchies, and a culture where every voice is heard. We are builders of well-being and offer jobs with a clear purpose: helping people live their lives to the fullest. Please visit our website to find further information about our values and Orion as an employer: https://www.orionpharma.com/careers/working-with-us/ What are we looking for? • 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. How to apply Please send your application with the latest CV and cover letter by July 26th, 2026. The expected annual salary range for this position is USD 100,000–180,000 for U.S.-based candidates, depending on skills, experience, and job-related qualifications. For UK-based candidates, compensation will be aligned with Orion’s salary range for the applicable grade. We typically review applications already during the application period and may start interviewing candidates before the application deadline. Therefore, we invite you to send your application as soon as possible. #LI-ORION Orion’s pharmaceutical innovations are created within its R&D organization. We employ over 400 top professionals in the field of drug discovery and development. We work globally: in Espoo and Turku in Finland, in Nottingham and Cambridge in the UK, and in Cambridge, MA, USA. Orion R&D and the Innovative Medicines business division are dedicated to making a transformation to become a global player in the pain and oncology therapy areas.