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Senior biostatistician

Saint-Gilles
CDI
DICE-CRO
Publiée le Publiée il y a 15 h
Description de l'offre

Principal Biostatistician – Clinical Development

Do you have the skills to fill this role Read the complete details below, and make your application today.About DICEDICE 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 RoleAs 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 ResponsibilitiesStatistical design and scientific inputContribute to the design of clinical studies, including sample size determination and appropriate statistical methodologiesProvide statistical input on study objectives, endpoints, estimands, and analysis strategies in collaboration with sponsor teamsSupport the preparation of statistical sections of regulatory briefing documents when requiredStatistical analysis and deliverablesLead the development of statistical analysis plans (SAPs)Oversee or review statistical analyses for clinical studies, including efficacy and safety analysesParticipate in Data Monitoring Committees (DMC/DSMB) or other study oversight committees when relevantPerform quality review of statistical outputs and deliverablesProject collaborationAct as a key statistical contact for assigned clinical studiesCollaborate with data management, statistical programming, medical writing, and clinical teamsContribute to discussions with sponsor teams on statistical aspects of ongoing studiesYou will work as part of a multidisciplinary team supporting biotechnology companies across the globe in early and late clinical development.ProfileWe are looking for an experienced statistician with strong analytical skills and the ability to communicate statistical concepts clearly to multidisciplinary teams.EducationMaster's degree (or higher) in statistics, biostatistics, mathematics, engineering, or another quantitative discipline.ExperienceAt least to 8–12 years of experience in biostatistics within the pharmaceutical, biotechnology, or CRO environmentExperience acting as lead statistician for clinical trialsFamiliarity with regulatory guidelines relevant to clinical research (ICH, EMA, FDA)Experience collaborating with multidisciplinary clinical development teamsExperience contributing to regulatory interactions with health authorities is considered an asset.SkillsSolid understanding of statistical methods used in clinical researchProgramming skills in SAS, R, and/or PythonStrong written and verbal communication skills in EnglishAbility to work both independently and collaborativelyClient-oriented mindset and attention to detailA background in a medical or life sciences field is considered a plus.What We OfferAt DICE, you will work in a scientifically driven environment where biometrics plays a central role in clinical development programs. xjsrcvqWe offer:The opportunity to work on innovative clinical development projectsCollaboration with experienced biometrics professionalsOpportunities for continuous professional developmentFlexible working conditionsA competitive compensation packageInterested?If you are interested in joining our team, please send your application to

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