03 ott - Modena
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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