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
Functional Leadership and Strategy
• 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.
What you can expect from us
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.
How to Apply
Please submit your application, including your CV, cover letter, and salary
request by October 18th, 2026. Please note that the applications are reviewed on
a rolling basis throughout the application period.
Approved medical examination which also includes drug testing is required prior
to the employment. We will also carry out a security clearance prior to the
employment for the selected person.
The expected annual base salary range for this position is up to $300,000 per
year for US based candidates. Final compensation will depend on skills,
experience, and job-related qualifications. In addition to base salary, Orion
offers competitive incentive opportunities, as well as a comprehensive benefits
package to support the wellbeing and success of our employees.
#LI-ORION
Your new team
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.
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.
About Orion [https://www.orionpharma.com/about-orion/]