Head of Statistical Programming (Oncology), Global Data Sciences, R&D, Orion Pharma

Orion Pharma; Espoo; On-site; EUR 150,000 - 230,000; Full time

Job summary

Orion Pharma seeks an experienced Head of Statistical Programming to build and lead a global coding organization in Oncology. You will shape strategy, operating model, and standards, while ensuring compliant, submission-ready outputs across clinical programs.

Reporting to the VP of Global Data Sciences, you will drive innovation, automation, and AI-enabled workflows, mentor a diverse team, and partner with Biostatistics, Regulatory Affairs, and Medical Writing to advance oncology programs in a

Qualifications

• 15+ years of statistical programming experience in pharma/biotech with oncology focus.
• Significant leadership experience managing global programming teams.
• Track record supporting global regulatory submissions (NDA/BLA/MAA).
• Deep expertise in CDISC SDTM, ADaM, and define.xml standards.
• Strong knowledge of SAS programming and clinical trial reporting.

Responsibilities

• Lead and develop the Statistical Programming function and capability.
• Define strategy, operating model, and roadmap aligned with Global Data Sciences.
• Ensure governance, accountability, and collaboration with partners.
• Provide oversight for SDTM/ADaM deliverables and regulatory submissions.

Skills

Leadership

Strategy

Stakeholder management

SAS programming

CDISC standards

SDTM/ADaM

R/Python

Cloud analytics

Automation

Regulatory submissions

Change management

Education

Master's degree in statistics / quantitative field

Tools

SAS

R

Python

Cloud platforms

Job description

We are seeking an experienced and visionary leader to establish and lead Orion's Statistical Programming function in Oncology. The Head of Statistical Programming provides strategic, operational, and technical leadership for the Statistical Programming function within Global Data Sciences organization. This role is accountable for building and leading a high-performing global programming organization that delivers high-quality, regulatory-compliant programming outputs supporting clinical development, regulatory submissions, and evidence generation across the portfolio. Reporting to the VP of Global Data Sciences, the Head of Statistical Programming is responsible for defining the Statistical Programming strategy, operating model, standards, and capabilities needed to support current and future development programs. The role partners closely with Biostatistics, Clinical Data Management, Clinical Development, Regulatory Affairs, Medical Writing, and external partners to ensure submission-ready programming deliverables are produced efficiently, consistently, and in compliance with global regulatory requirements. The Head of Statistical Programming plays a key role in advancing innovation, automation, standardization, and AI-enabled programming capabilities while fostering a culture of quality, collaboration, continuous improvement, and inspection readiness.

Key Responsibilities

• Lead and develop the Statistical Programming function, including organizational design, talent strategy, workforce planning, and capability development.
• Define and execute the Statistical Programming vision, strategy, operating model, and roadmap aligned with Global Data Sciences and R&D objectives.
• Establish clear roles, responsibilities, governance, and accountability across internal teams and external partners.

Portfolio and Delivery Oversight

• Provide oversight of programming activities across clinical studies and programs, ensuring high-quality and timely delivery of programming outputs.
• Ensure consistent execution of SDTM, ADaM, TLFs, define.xml, reviewer guides, and other submission-related deliverables across the portfolio.
• Monitor resource utilization, capacity, risks, timelines, and quality metrics to support successful study and program execution.
• Provide programming leadership for critical development milestones, regulatory interactions, and global health authority submissions.

Standards, Quality, and Regulatory Excellence

• Own and evolve Statistical Programming standards, processes, templates, conventions, and best practices.
• Ensure compliance with CDISC standards, global regulatory requirements, GxP expectations, and company procedures.
• Drive submission readiness by design through standardized, traceable, reproducible, and inspection-ready programming practices.
• Lead preparation and support for regulatory inspections and audits related to programming deliverables and processes.

Technology, Automation, and Innovation

• Establish the technology strategy for Statistical Programming, including programming platforms, standards repositories, automation frameworks, and development tools.
• Drive adoption of modern technologies, automation solutions, and AI-enabled workflows to improve efficiency, quality, scalability, and traceability.
• Partner with the broader organization to advance data-driven and AI-enabled ways of working.
• Evaluate and implement emerging programming methodologies, tools, and industry best practices.

People Leadership

• Recruit, develop, mentor, and retain statistical programming talent.
• Foster a culture of accountability, collaboration, innovation, continuous learning, and positive engagement.
• Provide coaching and professional development opportunities to strengthen technical and leadership capabilities within the team.
• Promote effective collaboration across Biostatistics, Clinical Data Management, Clinical Operations, and other functional areas.

At Orion, your work creates true impact and well-being for our customers, patients and society at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence. We offer a wealth of career paths and development opportunities that support the development of innovative solutions and improving the quality of life. Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/.

What We Are Looking For

• Master's degree or equivalent in Statistics, Biostatistics, Computer Science, Mathematics, Data Science, or a related quantitative discipline.
• 15+ years of statistical programming experience within the pharmaceutical or biotechnology industry, with oncology experience preferred.
• Significant leadership experience managing Statistical Programming organizations and global programming teams.
• Track record of leading programming support for global regulatory submissions, including NDA, BLA, MAA, or equivalent filings.
• Deep expertise in CDISC standards, including SDTM, ADaM, define.xml, controlled terminology, and submission requirements.
• Strong knowledge of SAS programming and clinical trial reporting methodologies.
• Experience with R, Python, cloud-based analytics environments, or other modern programming technologies.
• Demonstrated success implementing standards, automation, process improvements, and scalable operating models.
• Strong understanding of clinical development, regulatory expectations, and GxP requirements.
• Interest in emerging AI technologies and their practical application to statistical programming and drug development.
• Excellent leadership, communication, stakeholder management, and organizational skills.
• Ability to influence across functions, lead through change, and drive strategic initiatives in a global environment.

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.