Statistical Scientist Director

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/83lwp0

As 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.Le informazioni riportate di seguito illustrano i requisiti del ruolo, l'esperienza richiesta ai candidati e le qualifiche associate.Serve as lead statistician on complex client studies, acting as point-of-contact and aligning design, analyses, and interpretation across teamsCommunicate complex quantitative concepts to non-statistical stakeholders including sponsor leadership and regulatory representativesDevelop sample size estimation, adaptive or Bayesian trial designs, and innovative statistical approachesProvide senior oversight for SAPs, CSRs, and regulatory documents; select statistical deliverablesIdentify and mitigate risks related to study design, sample size, or analysisAct as project manager for biostatistics work, managing budget, scope,



and timelinesAdvise on regulatory guidelines and global submission expectations (FDA, EMA, PMDA)Support business development through bid defenses and capability presentations; build relationships with sponsors and influence decisionsParticipate as an independent biostatistician on DSMBs and DMCsMS or PhD in statistics or closely related field; equivalent combination considered15+ years’ experience in clinical trials design and analysis, preferably in CROAt least 1 year of experience in implementing innovative statistical designs in trialsStrong knowledge of regulatory, scientific, technical and clinical aspects xysqume of clinical trials in relevant therapeutic areasProficiency in SAS and R; experience with CDISC standardsAbility to interact with regulatory agencies (FDA, EMA, etc.)Excellent English and host country communication skills; strong organizational and time-management abilitiesWillingness to travel (~20%)excellent communication and presentation skillsleadership and team coordinationability to manage difficult client situationsSASRCDISC standardsStatistical Scientist Director verona, veneto, it#J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/83lwp0