Orion Pharma
Statistical Programming Lead, Clinical Data Management, R&D, Orion Corporation
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Job Description
You 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.
This role 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.
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.
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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 here.
What We Are Looking For
- 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.
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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 130,000–230,000 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.
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.
About Us
Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.
We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.
Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.
We offer careers with a clear purpose: empowering people to live their lives to the fullest.
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