Statistical Scientist Director

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