Descripción de la oferta
We are seeking an experienced and proactiveSenior Biostatistician to join our FSP team, supporting a global pharmaceutical client. This is apermanent, home-based position offering the opportunity to work onlate-phase global oncology trials , with a focus onhematology andregulatory submissions . Key Responsibilities Serve as thelead statistician on globallate-phase registration trials , particularly in oncology (hematology preferred). Independently contribute tostudy design ,statistical analysis plans (SAPs) , andregulatory submission strategies . Participate instudy team meetings , providing statistical guidance and collaborating with cross-functional teams. Addresshealth authority questions and support responses with appropriate statistical analyses and documentation. Performhands-on statistical programming to derive outputs and summary statistics usingADaM andSDTM datasets. Ensure timely and accurate delivery of statistical deliverables in compliance with regulatory standards Required Qualifications Advanced degree (Master’s or PhD) inBiostatistics ,Statistics , or a related field. 5+ years of experience in clinical trials, with a strong focus ononcology (hematology and late-phase preferred). Proven experience working onregistrational studies andregulatory submissions . Strong knowledge ofCDISC standards , particularlyADaM andSDTM . Proficiency inSAS programming and ability to perform hands-on statistical analyses. Excellent communication skills and ability to work independently in a global, cross-functional environment. Preferred Experience Prior involvement inFDA/EMA submissions . Experience addressingregulatory agency queries . Familiarity withreal-world evidence andobservational studies is a plus. Why Join Us? Work onhigh-impact global studies with a focus on improving cancer treatment outcomes. Be part of acollaborative and innovative team environment. Enjoy theflexibility of remote work with a permanent contract. Gain exposure toregulatory strategy andcutting-edge oncology research . IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at