Principal Statistician

01 ott - Milano
Warman O'Brien

ph3bPrincipal Biostatistician (strong Seniors considered) – Global Pharma | Italy (Hybrid) /b /h3 h3bShape the Future of Drug Development /b /h3 pAre you an experienced statistician ready to take your expertise to the next level? Our client, a leading international pharmaceutical company, is looking for a bPrincipal Biostatistician /b to join their dynamic and collaborative team. If you're passionate about designing meaningful clinical trials and influencing global health outcomes, this is the opportunity for you. /p h3bWhat You'll Be Doing /b /h3 pAs a key statistical expert, you'll play a pivotal role across all phases of clinical development—from strategy through execution. You'll partner with cross-functional teams and external vendors to ensure the scientific integrity and success of clinical trials. /p h3bYour responsibilities will include: /b /h3 ul liDesigning innovative and efficient clinical trials (Phases I–IV), including defining study populations and endpoints aligned with key objectives. /li liLeading the development and review of protocols, statistical analysis plans (SAPs), study reports, and publication materials. /li liPresenting data and insights in a clear, concise, and transparent manner to internal teams and regulatory bodies. /li liServing as a statistical lead across multiple studies, ensuring high-quality, standardized outputs within a therapeutic area. /li liActing as a primary point of contact for CROs and vendors, managing Biostatistics deliverables end-to-end.



/li liApplying advanced statistical methodologies and ensuring regulatory readiness of all deliverables. /li liContributing strategic insights across clinical development, regulatory, market access, and medical affairs functions. /li liMentoring junior statisticians and supporting team knowledge growth. /liliPreparing for and supporting Health Authority inspections and audits. /li /ul h3bWhat We're Looking For /b /h3 ul libPhD /b (6+ years' experience) or bMS /b (8+ years' experience) in Biostatistics, Statistics, or related field. /li liProven experience in the pharmaceutical industry or CRO environment. /liliStrong proficiency in bSAS /b, bR /b, or bPython /b. /li liDeep understanding of statistical methodologies related to clinical trials and real-world evidence. /li liExperience in rare disease is a plus. /li liFamiliarity with regulatory and HTA (Health Technology Assessment) processes is highly desirable. /liliStrong communication skills, with the ability to translate complex data into actionable insights. /li /ul h3bWhy Join This Team? /b /h3 ul liWork with a top-tier pharmaceutical company with a global footprint /li liBe part of a collaborative, science-driven culture /li liInfluence projects from early development through to regulatory approval /li liEnjoy flexibility with a bhybrid / remote work model /b based in Italy /li liMake a tangible impact on the future of medicine – especially in brare and complex diseases /b /li /ul pReady to make a difference in your next role? /p /p #J-*****-Ljbffr

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