Role Overview: The Director serves as a statistical expert supporting clinical development, acting as a lead for specific compounds and indications. They contribute to strategies, plans, and regulatory interactions, ensuring consistency and scientific rigor across trials.
Key Responsibilities:
- Lead statistical activities for designated compounds/indications, advising on methodologies and engaging with regulatory authorities.
- Support clinical strategies, develop trial designs, analyses, and integrated data plans.
- Represent the organization at regulatory meetings, Key Opinion Leader engagements, and scientific forums.
- Oversee trial-level activities including protocol reviews, statistical analysis plans, data transfer coordination, and ensuring compliance with standards.
- Participate in vendor oversight, CRO collaboration, and regulatory submissions.
- Mentor teams, review study documentation, and ensure high-quality, compliant statistical work.
Qualifications & Skills:
- Master’s or PhD in statistics or related field.
- Extensive experience (preferably 12+ years) in statistical analysis, modeling, adaptive trial designs, and drug development, particularly biologics or targeted therapies.
- Proficiency with regulatory standards (FDA, EMA, ICH), SDTM, ADaM, CDISC.
- Leadership skills with prior team management and project oversight experience.
This role requires a strategic thinker with advanced technical expertise, capable of driving innovative statistical approaches in clinical development to support the advancement of groundbreaking therapies.