15 set - Catania
Premier Research
Overview 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.
Responsabilità
Serve as lead statistician on complex client studies, acting as point-of-contact and aligning design, analyses, and interpretation across teams Communicate complex quantitative concepts to non-statistical stakeholders including sponsor leadership and regulatory representatives Develop sample size estimation, adaptive or Bayesian trial designs, and innovative statistical approaches Provide senior oversight for SAPs, CSRs, and regulatory documents; select statistical deliverables Identify and mitigate risks related to study design, sample size, or analysis Act as project manager for biostatistics work, managing budget, scope,
and timelines Advise 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 decisions Participate as an independent biostatistician on DSMBs and DMCs
Requisiti fondamentali
MS or PhD in statistics or closely related field; equivalent combination considered 15+ years’ experience in clinical trials design and analysis, preferably in CRO At least 1 year of experience in implementing innovative statistical designs in trials Strong knowledge of regulatory, scientific, technical and clinical aspects of clinical trials in relevant therapeutic areas Proficiency in SAS and R; experience with CDISC standards Ability to interact with regulatory agencies (FDA, EMA, etc.) Excellent English and host country communication skills; strong organizational and time-management abilities Willingness to travel (~20%) excellent communication and presentation skills leadership and team coordination ability to manage difficult client situations SAS R CDISC standards
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