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.
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 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.
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.
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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.
