Principal Biostatistician – Clinical Development
About DICE
DICE is a Contract Research Organization specialized in biometrics, including clinical study design, data management, biostatistics, central imaging review and medical writing. Since its foundation in 1989, DICE has supported biotechnology companies and pharmaceutical companies worldwide in the design and execution of clinical trials.
DICE is recognized for its strong scientific expertise and commitment to high-quality deliverables. Our teams work closely with biotech sponsors on innovative clinical development programs, primarily in interventional studies.
To support our continued growth, we are looking for an experienced Principal Biostatistician to strengthen our biometrics team. In this role, you will contribute to both the statistical execution and the scientific aspects of clinical study design and analysis, working in close collaboration with sponsors and multidisciplinary project teams.
The Role
As a Principal Biostatistician, you will contribute to the statistical design, analysis, and interpretation of clinical studies. You will work closely with sponsor teams and internal experts to ensure that statistical aspects of studies are aligned with scientific objectives and regulatory expectations.
The role combines hands-on statistical work with scientific input into study design and clinical development discussions. Depending on the project, you may also contribute to regulatory interactions and multidisciplinary project teams.
Key Responsibilities
Statistical design and scientific input
* Contribute to the design of clinical studies, including sample size determination and appropriate statistical methodologies
* Provide statistical input on study objectives, endpoints, estimands, and analysis strategies in collaboration with sponsor teams
* Support the preparation of statistical sections of regulatory briefing documents when required
Statistical analysis and deliverables
* Lead the development of statistical analysis plans (SAPs)
* Oversee or review statistical analyses for clinical studies, including efficacy and safety analyses
* Participate in Data Monitoring Committees (DMC/DSMB) or other study oversight committees when relevant
* Perform quality review of statistical outputs and deliverables
Project collaboration
* Act as a key statistical contact for assigned clinical studies
* Collaborate with data management, statistical programming, medical writing, and clinical teams
* Contribute to discussions with sponsor teams on statistical aspects of ongoing studies
You will work as part of a multidisciplinary team supporting biotechnology companies across the globe in early and late clinical development.
Profile
We are looking for an experienced statistician with strong analytical skills and the ability to communicate statistical concepts clearly to multidisciplinary teams.
Education
Master’s degree (or higher) in statistics, biostatistics, mathematics, engineering, or another quantitative discipline.
Experience
* At least to 8–12 years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO environment
* Experience acting as lead statistician for clinical trials
* Familiarity with regulatory guidelines relevant to clinical research (ICH, EMA, FDA)
* Experience collaborating with multidisciplinary clinical development teams
* Experience contributing to regulatory interactions with health authorities is considered an asset.
Skills
* Solid understanding of statistical methods used in clinical research
* Programming skills in SAS, R, and/or Python
* Strong written and verbal communication skills in English
* Ability to work both independently and collaboratively
* Client-oriented mindset and attention to detail
* A background in a medical or life sciences field is considered a plus.
What We Offer
At DICE, you will work in a scientifically driven environment where biometrics plays a central role in clinical development programs.
We offer:
* The opportunity to work on innovative clinical development projects
* Collaboration with experienced biometrics professionals
* Opportunities for continuous professional development
* Flexible working conditions
* A competitive compensation package
Interested?
If you are interested in joining our team, please send your application to nadia.verbruggen@dice-cro.com