Principal Biostatistician

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pbUnited States or Italy | Remote | Full-time /b /p h3About Valos /h3 pValos is an international biometrics CRO providing Biostatistics, Statistical Programming and Clinical Data Management services to pharmaceutical, biotechnology and medical device companies.
/p pWe are building the next stage of our Statistics organization and are looking for a bPrincipal Biostatistician /b who combines strong clinical-trial expertise with scientific advisory, people development and curiosity about how AI can change statistical work.
/p pThis 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.
/p h3What you will do /h3 ul liProvide senior statistical leadership for clinical trials and development programs, including study design, protocols, SAPs, estimands, analysis strategy and interpretation.
/li liAct as a scientific advisor to sponsors — understanding the problem behind the request, challenging approaches when appropriate and proposing better statistical solutions.
/li liMentor and develop statisticians, helping them progress from strong technical executors to independent scientific advisors.
/li liLead selected complex studies and provide senior statistical review and oversight.
/li liHelp develop practical bAI-enabled statistical workflows /b, while ensuring appropriate validation, traceability and human statistical oversight.
/li liSupport client meetings, proposals and bid defenses and help identify opportunities where broader Valos capabilities can solve sponsor problems.
/li liContribute to new methodologies,



processes and statistical capabilities across Valos.
/li /ul h3What we are looking for /h3 ul liApproximately b10+ years of experience in pharmaceutical, biotech or CRO biostatistics /b.
/li liStrong experience as a Lead, Principal or senior study/program statistician.
/li liMSc or PhD in Statistics, Biostatistics or a related quantitative discipline.
/li liStrong clinical-trial experience, including protocols, SAPs, statistical analyses and interpretation of results.
/li liDemonstrated ability to interact directly with pharmaceutical/biotech sponsors and provide statistical recommendations.
/li liExperience mentoring, developing or leading other statisticians.
/li liStrong SAS knowledge and experience with R and/or Python.
/li liUnderstanding of regulatory requirements and modern clinical-trial methodology.
/li liCRO and/or FSP experience is highly desirable.
/li /ul pExperience with areas such as bestimands, missing-data methodology, longitudinal models, time-to-event analysis, adaptive designs, Bayesian methods, simulation, RWE/RWD or causal inference /b would be particularly valuable.
/p h3AI and innovation /h3 pYou do bnot /b need to be an AI engineer.




/p pWe are interested in statisticians who are already exploring how generative AI, automation and modern analytical tools can improve statistical work.
/p pWe 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.
/p pWe 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.
/p h3What success looks like /h3 pWithin your first year, we expect you to: /p ul liestablish credibility as a senior scientific advisor with our clients; /li lisuccessfully lead selected complex studies or programs; /li lidevelop a group of statisticians toward greater independence and stronger sponsor interaction; /li lihelp our FSP statisticians become more proactive scientific partners; /li liintroduce and validate practical AI-enabled improvements to statistical workflows; /li listrengthen our statistical capabilities and operating model; /li licontribute scientifically to new and existing client relationships.
/li /ul h3Why Valos /h3 pThis role offers something different from a traditional Principal Biostatistician position.
/p pYou will have the opportunity to influence bhow a growing Statistics organization works /b, develop other statisticians, work directly with senior leadership and clients, and help shape how AI is introduced into regulated statistical processes.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8hq0mt