In sintesi
- Mansioni: Guida strategie statistiche per studi complessi e comunica concetti quantitativi a stakeholder non statistici.
- Azienda: Azienda innovativa nel settore biotech, medtech e pharma.
- Benefit: Opportunità di impatto reale e crescita professionale in un ambiente dinamico.
- Altre informazioni: Possibilità di viaggiare e interagire con agenzie regolatorie.
- Perché questo lavoro: Modifica il design degli studi clinici e collabora con leader del settore.
- Qualifiche: MS o PhD in statistica e 15+ anni di esperienza in trial clinici.
La retribuzione prevista è compresa tra 144000 - 176000 € per anno.
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 Ph D 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
Statistical Scientist Director datore di lavoro: Premier Research
Come Direttore Scientifico Statistico, avrai l'opportunità di guidare strategie statistiche per studi complessi nel settore biotech, medtech e farmaceutico, contribuendo a progetti innovativi che hanno un impatto significativo. La nostra cultura aziendale promuove la crescita professionale attraverso opportunità di sviluppo e formazione continua, mentre il nostro ambiente collaborativo ti permetterà di lavorare a stretto contatto con leader del settore e agenzie regolatorie. Offriamo un pacchetto di benefici competitivo e la possibilità di influenzare decisioni strategiche, rendendo il tuo lavoro non solo significativo ma anche gratificante.
