Statistical Programming Lead, Clinical Data Management, R&D

Statistical Programming Lead, Clinical Development Data Services, R&D, Orion Corporation

and 1 more

and 1 more

You will join a growing oncology-focused Data Sciences function and provide hands‑on leadership and technical oversight 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 delivering high-quality, regulatory‑compliant programming outputs that support clinical development, regulatory submissions, and study decision-making.

This role partners closely with Biostatistics, Data Management, Clinical Development, Regulatory Affairs, Medical Writing, and external service providers to execute programming plans, apply programming standards, support submission readiness, and ensure efficient delivery of programming outputs across studies and programs.

• Serve as the Statistical Programming Lead for assigned oncology studies and programs, providing hands‑on technical leadership from study startup through regulatory submission.
• Represent Statistical Programming on cross‑functional study and program teams and translate study objectives, SAPs, and submission requirements into executable programming deliverables.
• Lead and contribute to the development, validation, QC, and delivery of SDTM, ADaM, TLFs, define.xml files, reviewer guides, and other submission‑related programming deliverables.
• Ensure programming deliverables are completed with high quality, on schedule, and in compliance with regulatory requirements and company standards.
• Contribute to the development, maintenance, and implementation of programming standards, tools, templates, macros, and best practices.
• Apply subject matter expertise in CDISC standards, regulatory submission requirements, and programming methodologies to ensure traceable, reproducible, and submission‑ready deliverables.
• Collaborate with Biostatistics to implement Statistical Analysis Plans, mock TLFs, and reporting requirements, ensuring consistent and accurate statistical deliverables.
• Support regulatory filing activities, including development and quality review of programming deliverables for NDA, BLA, and MAA submissions.
• Drive continuous improvement, automation, and appropriate use of AI‑assisted programming tools to improve programming efficiency, quality, traceability, and scalability.
• Provide technical guidance, mentoring, and quality review support to programmers, as needed.

This role can be based in Cambridge (MA) or in Cambridge, UK and reports to Head of Clinical Development Data Services.

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:

• Bachelor's, Master's, or equivalent degree in Statistics, Biostatistics, Computer Science, Mathematics, or related quantitative discipline.
• 10+ years of statistical programming experience within the pharmaceutical or biotechnology industry, oncology preferred.
• Demonstrated experience serving as a hands‑on programming lead for clinical studies and regulatory submission activities.
• 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…