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Orion Pharma

Associate Director, Biostatistics, R&D, Orion Corporation

Posted 6 Hours Ago
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Hybrid
Boston, MA
Expert/Leader
Hybrid
Boston, MA
Expert/Leader
Provide strategic biostatistics leadership for oncology Phase I-III programs: design studies, develop SAPs, support regulatory submissions, lead cross-functional teams, standardize methodologies, advance Bayesian and adaptive methods, and drive adoption of AI-enabled analytics and automation across the Biostatistics function.
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You will join a growing oncology-focused Data Sciences function and provide strategic statistical leadership for oncology drug development programs across Phase I–III clinical development. This role is responsible for developing and executing statistical strategies that support study design, regulatory submissions, data interpretation, and key development decisions across the oncology portfolio.

The Associate Director of Biostatistics serves as a key representative of Biostatistics on cross-functional teams and contributes to the growth, development, and continuous improvement of the broader Data Sciences organization.
 

Responsibilities

  • Provide scientific and strategic biostatistics leadership for oncology portfolio across Phase I-III studies
  • Contribute to clinical development plans, study designs, and evidence-generation strategies as a core member of program teams
  • Serve as the lead statistician for assigned development programs and represent Biostatistics on cross-functional study and program teams.
  • Lead the development and review of protocols, statistical analysis plans (SAPs), clinical study reports, and other key study documents.
  • Ensure delivery of biostatistics outputs across the portfolio in line with timelines, budget, quality, and compliance expectations
  • Provide statistical leadership for regulatory submissions (e.g. NDA/BLA/MAA) and health authority interactions
  • Define, standardise, and drive implementation of statistical methodologies, standards, and best practices across the function
  • Represent biostatistics in governance forums, cross-functional leadership teams, and external collaborations
  • Advance the application of advanced and innovative statistical approaches (e.g. Bayesian and adaptive statistical methods)
  • Lead the evaluation and adoption of AI-enabled analytics, automation, and advanced decision-support capabilities across the Biostatistics function
  • Partner with Data Sciences and Programming leaders to identify opportunities for AI-assisted evidence generation and operational efficiency improvements.


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
  • 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 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.

About Orion

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