Statistical Scientist Director

About the role

Premier Research seeks a Statistical Scientist Director to lead complex biostatistics projects for biotech, medtech and specialty pharma clients. You will shape statistical strategy from protocol design through regulatory reporting.

Key responsibilities

• Lead statistician on key client studies, managing communication with sponsors and internal teams and overseeing statistical strategy from protocol/SAP planning to reporting.
• Develop sample size calculations, adaptive/Bayesian designs, modeling approaches and innovative trial designs.
• Provide senior oversight for statistical deliverables such as SAPs, randomization specifications, CSR contributions and regulatory documents.
• Identify design or analysis risks and propose mitigation strategies while managing project budget, scope and timeline.
• Advise clients on regulatory guidelines (FDA, EMA, PMDA) and support business development activities.

Required profile

• Advanced degree (MS or PhD) in statistics or a related field.
• 15+ years of experience in clinical trial design and analysis, preferably in a CRO environment.
• Strong knowledge of regulatory requirements and CDISC standards.
• Excellent communication skills in English and ability to manage client relationships.

Required skills

• Advanced programming with SAS.
• Statistical analysis using R.
• Application of CDISC standards to projects.