Senior Biostatistician – Oncology

7 giorni fa

Rome, Italia Altro A tempo pieno

Social network you want to login/join with: col-narrow-left Client:IQVIA Location:Job Category:Other - EU work permit required:Yes col-narrow-right Job Reference:db174f4fbb08 Job Views:3 Posted: Expiry Date: col-wide Job Description:We are seeking an experienced and proactiveSenior Biostatisticianto join our FSP team, supporting a global pharmaceutical client. This is apermanent, home-basedposition offering the opportunity to work onlate-phase global oncology trials , with a focus onhematologyandregulatory submissions . Key Responsibilities Serve as thelead statisticianon 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 questionsand support responses with appropriate statistical analyses and documentation. Performhands-on statistical programmingto derive outputs and summary statistics usingADaMandSDTMdatasets. 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+ yearsof experience in clinical trials, with a strong focus ononcology(hematology and late-phase preferred). Proven experience working onregistrational studiesandregulatory submissions . Strong knowledge ofCDISC standards , particularlyADaMandSDTM . Proficiency inSASprogramming 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 evidenceandobservational studiesis a plus. Why Join Us? Work onhigh-impact global studieswith a focus on improving cancer treatment outcomes. Be part of acollaborative and innovativeteam environment. Enjoy theflexibility of remote workwith a permanent contract. Gain exposure toregulatory strategyandcutting-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#J-18808-Ljbffr

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    Social network you want to login/join with:col-narrow-leftClient: IQVIALocation: Job Category: Other-EU work permit required: Yescol-narrow-rightJob Reference: db174f4fbb08Job Views: 3Posted: Expiry Date: col-wideJob Description: We are seeking an experienced and proactive Senior Biostatistician to join our FSP team, supporting a global pharmaceutical...

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