Statistical Scientist Director

ppAs Statistical Scientist Director, you will lead statistical strategy for complex client studies, guiding design through reporting. You will translate quantitative concepts for non-statistical stakeholders and oversee innovative analysis approaches. You’ll manage deliverables, risk mitigation, and regulatory alignment, while supporting business development and client relationships. This role offers impact across biotech, medtech, and pharma initiatives and opportunities to shape cutting-edge trial designs. /pulliServe as lead statistician on complex client studies, acting as point-of-contact and aligning design, analyses, and interpretation across teams /liliCommunicate complex quantitative concepts to non-statistical stakeholders including sponsor leadership and regulatory representatives /liliDevelop sample size estimation, adaptive or Bayesian trial designs, and innovative statistical approaches /liliProvide senior oversight for SAPs, CSRs, and regulatory documents; select statistical deliverables /liliIdentify and mitigate risks related to study design, sample size, or analysis /liliAct as project manager for biostatistics work, managing budget, scope, and timelines /liliAdvise on regulatory guidelines and global submission expectations (FDA, EMA, PMDA) /liliSupport business development through bid defenses and capability presentations; build relationships with sponsors and influence decisions /liliParticipate as an independent biostatistician on DSMBs and DMCs /liliMS or PhD in statistics or closely related field; equivalent combination considered /lili15+ years’ experience in clinical trials design and analysis, preferably in CRO /liliAt least 1 year of experience in implementing innovative statistical designs in trials /liliStrong knowledge of regulatory, scientific, technical and clinical aspects of clinical trials in relevant therapeutic areas /liliProficiency in SAS and R; experience with CDISC standards /liliAbility to interact with regulatory agencies (FDA, EMA, etc.) /liliExcellent English and host country communication skills; strong organizational and time-management abilities /liliWillingness to travel (~20%) /liliexcellent communication and presentation skills /lilileadership and team coordination /liliability to manage difficult client situations /liliSAS /liliR /liliCDISC standards /li /ulpStatistical Scientist Director terni, umbria, it /p /p #J-18808-Ljbffr