Statistical Scientist Director

Overview

As Statistical Scientist Director, you lead statistical strategy for complex client studies, guiding protocol planning, SAPs, and reporting while ensuring design and interpretation align with study objectives. You’ll communicate advanced quantitative concepts to sponsors, regulators, and clinical teams, shaping innovative trial designs and Bayesian or adaptive approaches. You will oversee statistical deliverables, manage risks, and drive high-quality outputs within timelines and budgets. This role sits at the core of Biostatistics, enabling life-saving medicines and devices through expert collaboration and strategic leadership. Your work supports regulatory submissions and informs evidence‑f

Responsibilities

• Serve as lead statistician on key client studies and act as point-of-contact for sponsors and internal teams; drive project-level statistical strategy from protocol to reporting.
• Communicate complex quantitative concepts clearly to non-statistical stakeholders, including sponsor leadership, regulatory representatives, and clinical teams.
• Develop sample size estimation, modeling approaches, adaptive or Bayesian frameworks, and innovative trial designs.
• Provide senior oversight for statistical deliverables (protocols, SAPs, randomization specs, CSRs, publications, regulatory documents).
• Identify design/analysis risks and proactively propose mitigation strategies.
• Act as project manager for biostatistics stand-alone work; manage budget, scope, and timelines to deliver high-quality outputs.
• Advise clients on regulatory guidelines and global expectations (FDA, EMA, PMDA) for submissions.
• Support business development through bid defenses, capability presentations, RFP strategy, and building trusted sponsor relationships.
• Serve as an independent biostatistician on DSMBs and DMCs

Key requirements

• Advanced degree (MS or PhD) in statistics or closely related field (or equivalent experience)
• 15+ years’ experience in clinical trials design and analysis, preferably in CRO
• At least 1 year of technical experience implementing innovative statistical designs
• Experience with innovative statistical designs and regulatory-driven submissions
• Strong knowledge of regulatory, scientific, technical and clinical aspects of clinical trials in relevant therapeutic areas
• Strong programming skills with SAS and R
• Excellent working knowledge of CDISC standards and their application
• Ability to manage difficult client and team situations
• Experience interacting with regulatory agencies (FDA, EMA, etc.)
• Excellent English and Host Country communication skills
• Excellent organizational and time-management skills; able to prioritize multiple tasks in dynamic environments
• Willingness to travel (~20%)

• Clear communication of complex concepts
• Leadership and project management
• Client relationship building
• SAS
• R
• CDISC standards

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