Statistical Scientist Director

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8c3kc7

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.)
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8c3kc7