Principal Biostatistician

Principal Biostatistician – Scientific Advisory & Innovation

United States or Italy | Remote | Full-time

About Valos

Valos is an international biometrics CRO providing Biostatistics, Statistical Programming and Clinical Data Management services to pharmaceutical, biotechnology and medical device companies.

We are building the next stage of our Statistics organization and are looking for a Principal Biostatistician who combines strong clinical-trial expertise with scientific advisory, people development and curiosity about how AI can change statistical work.

This is not purely a study-delivery position. You will work closely with our Head of Biostatistics and senior management to help develop both our people and our statistical capabilities.

What you will do

• Provide senior statistical leadership for clinical trials and development programs, including study design, protocols, SAPs, estimands, analysis strategy and interpretation.
• Act as a scientific advisor to sponsors — understanding the problem behind the request, challenging approaches when appropriate and proposing better statistical solutions.
• Mentor and develop statisticians, helping them progress from strong technical executors to independent scientific advisors.
• Lead selected complex studies and provide senior statistical review and oversight.
• Help develop practical AI-enabled statistical workflows, while ensuring appropriate validation, traceability and human statistical oversight.
• Support client meetings, proposals and bid defenses and help identify opportunities where broader Valos capabilities can solve sponsor problems.
• Contribute to new methodologies, processes and statistical capabilities across Valos.

What we are looking for

• Approximately 10+ years of experience in pharmaceutical, biotech or CRO biostatistics.
• Strong experience as a Lead, Principal or senior study/program statistician.
• MSc or PhD in Statistics, Biostatistics or a related quantitative discipline.
• Strong clinical-trial experience, including protocols, SAPs, statistical analyses and interpretation of results.
• Demonstrated ability to interact directly with pharmaceutical/biotech sponsors and provide statistical recommendations.
• Experience mentoring, developing or leading other statisticians.
• Strong SAS knowledge and experience with R and/or Python.
• Understanding of regulatory requirements and modern clinical-trial methodology.
• CRO and/or FSP experience is highly desirable.

Experience with areas such as estimands, missing-data methodology, longitudinal models, time-to-event analysis, adaptive designs, Bayesian methods, simulation, RWE/RWD or causal inference would be particularly valuable.

AI and innovation

You do not need to be an AI engineer.

We are interested in statisticians who are already exploring how generative AI, automation and modern analytical tools can improve statistical work.

We would particularly like to hear from candidates who can give concrete examples of how they have used AI or automation for activities such as statistical research, protocol/SAP review, programming, QC, documentation, analysis interpretation or process improvement.

We believe AI will augment rather than replace the clinical statistician. The opportunity is to automate lower-value work while allowing statisticians to spend more time on scientific judgment, problem solving and client advisory.

What success looks like

Within your first year, we expect you to:

• establish credibility as a senior scientific advisor with our clients;
• successfully lead selected complex studies or programs;
• develop a group of statisticians toward greater independence and stronger sponsor interaction;
• help our FSP statisticians become more proactive scientific partners;
• introduce and validate practical AI-enabled improvements to statistical workflows;
• strengthen our statistical capabilities and operating model;
• contribute scientifically to new and existing client relationships.

Why Valos

This role offers something different from a traditional Principal Biostatistician position.

You will have the opportunity to influence how a growing Statistics organization works, develop other statisticians, work directly with senior leadership and clients, and help shape how AI is introduced into regulated statistical processes.