31 lug - Milano
Warman O'Brien
ph3Principal Biostatistician (strong Seniors considered) – Global Pharma | Italy (Hybrid) /h3h3Shape the Future of Drug Development /h3pAre 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. /ph3What You’ll Be Doing /h3pAs 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. /ph3Your responsibilities will include: /h3ulliDesigning innovative and efficient clinical trials (Phases I–IV), including defining study populations and endpoints aligned with key objectives. /liliLeading the development and review of protocols, statistical analysis plans (SAPs), study reports, and publication materials. /liliPresenting data and insights in a clear, concise, and transparent manner to internal teams and regulatory bodies. /liliServing as a statistical lead across multiple studies, ensuring high-quality, standardized outputs within a therapeutic area. /liliActing as a primary point of contact for CROs and vendors, managing Biostatistics deliverables end-to-end.
/liliApplying advanced statistical methodologies and ensuring regulatory readiness of all deliverables. /liliContributing strategic insights across clinical development, regulatory, market access, and medical affairs functions. /liliMentoring junior statisticians and supporting team knowledge growth. /liliPreparing for and supporting Health Authority inspections and audits. /li /ulh3What We’re Looking For /h3ullibPhD /b (6+ years’ experience) or bMS /b (8+ years’ experience) in Biostatistics, Statistics, or related field. /liliProven experience in the pharmaceutical industry or CRO environment. /liliStrong proficiency in bSAS /b, bR /b, or bPython /b. /liliDeep understanding of statistical methodologies related to clinical trials and real-world evidence. /liliExperience in rare disease is a plus. /liliFamiliarity 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 /ulh3Why Join This Team? /h3ulliWork with a top‑tier pharmaceutical company with a global footprint /liliBe part of a collaborative, science‑driven culture /liliInfluence projects from early development through to regulatory approval /liliEnjoy flexibility with a bhybrid / remote work model /b based in Italy /liliMake a tangible impact on the future of medicine – especially in brare and complex diseases /b /li /ul /p #J-18808-Ljbffr
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