You will join a growing oncology-focused Data Sciences function and serve as the lead statistician for one or more oncology development programs, providing statistical leadership across Phase I–III clinical trials. This role is responsible for developing and executing statistical strategies that support study design, regulatory submissions, data interpretation, and key development decisions throughout the clinical development lifecycle.
The Associate Director of Biostatistics serves as the primary statistical representative on cross-functional study and program teams and provides expert scientific input to support development strategy, regulatory interactions, and evidence generation activities.
Responsibilities
- Serve as the lead statistician for late-stage oncology studies, including Phase III registrational trials, providing statistical leadership from protocol development through submission and post-submission activities.
- Contribute to clinical development strategies, study designs, endpoint selection, and evidence-generation plans as a core member of cross-functional program teams.
- Lead the development and review of protocols, statistical analysis plans (SAPs), clinical study reports, and other key study documents.
- Ensure delivery of high-quality biostatistics deliverables for assigned studies and programs in alignment with timeline, quality, and regulatory expectations.
- Lead statistical contributions to regulatory submissions (e.g., NDA/BLA/MAA) and health authority interactions.
- Contribute to the development and implementation of statistical methodologies, standards, and best practices that support consistent and high-quality study execution.
- Represent Biostatistics on cross-functional program teams, study governance meetings, and scientific collaborations.
- Advance the application of advanced and innovative statistical approaches (e.g. Bayesian and adaptive statistical methods).
- Evaluate and apply AI-enabled analytics, automation, and advanced decision-support capabilities to enhance statistical efficiency, evidence generation, and decision-making for assigned development programs.
Partner with Data Sciences and Statistical Programming to identify and implement AI-assisted approaches that improve evidence generation, operational efficiency, and analytical workflows.
This role is based in Cambridge (MA), US or Cambridge, UK and reports to Head of Biostatistics.
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.orion.fi/en/careers/orion-as-an-employer/.
What are we looking for?
- PhD or MSc in Statistics, Biostatistics, or a related field (PhD preferred).
- 10+ years of experience in clinical drug development, oncology preferred.
- Demonstrated experience serving as lead statistician for late-stage oncology clinical trials, including Phase III studies and regulatory submissions.
- Extensive regulatory experience (FDA, EMA, ICH), including leading or contributing to multiple marketing submissions.
- Deep expertise in oncology; experience in IO and/or ADC is a strong advantage.
- Strong command of advanced statistical approaches (e.g. Bayesian and adaptive designs) and their application in oncology.
- Excellent leadership, strategic-thinking, collaboration, and communication skills.
- Understanding of AI-assisted statistical workflows and emerging technologies applicable to drug development and evidence generation.
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 130,000–300,000 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.
#LI-ORION
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 UsOrion 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
Skills Required
- PhD or MSc in Statistics, Biostatistics, or a related field (PhD preferred)
- 10+ years of experience in clinical drug development
- Experience serving as lead statistician for late-stage oncology clinical trials, including Phase III studies and regulatory submissions
- Extensive regulatory experience with FDA, EMA, ICH and contributing to marketing submissions
- Strong command of advanced statistical approaches (e.g., Bayesian and adaptive designs)
- Deep expertise in oncology (experience in IO and/or ADC is a strong advantage)
- Excellent leadership, strategic-thinking, collaboration, and communication skills
- Understanding of AI-assisted statistical workflows and emerging technologies applicable to drug development
What We Do
Orion is a globally operating Nordic pharmaceutical company and builder of well-being. Rooted in Nordic values of trust and openness, the company focuses on developing treatments and conducting research to empower people to live their lives to the fullest. Operating in over 35 countries, Orion drives innovation in healthcare to improve health outcomes for millions of people worldwide.
