Sr. Director, Statistics

Role Summary

Senior Director in Statistics to lead execution and delivery across Therapeutic Area Units, Business Units, or SQS functional areas in preclinical to translational stages. Provide cross-functional leadership and accountable decision-making to impact R&D, define strategic delivery missions, identify risks and mitigation strategies, and drive growth of SQS delivery capabilities. Inspire and influence internal stakeholders and external partners, delivering long-term delivery innovation.

Responsibilities

• Play key role in execution and delivery leadership of Therapeutic Area Unit (TAU), Business Unit (BU), or SQS function or specialty area in preclinical / clinical / translational
• Be the cross functional leader and accountable execution and delivery decision maker that has direct impact on R&D
• Define and contribute to execution and delivery strategic mission and the respective implementation for the promotion of R&D seamless and predictable delivery
• Proactively identify risks and mitigation strategies to optimize R&D business impact in terms of costs, quality, and timeliness
• Be accountable for growth and development of SQS delivery capabilities through processes, systems and oversight mechanisms
• Show influential execution and delivery leadership both within and outside of Takeda with vendors and partners
• Provide strategic vision for long-term delivery innovation

Qualifications

• Desired education qualifications and equivalencies (e.g., PhD degree in a scientific discipline with 12+ years‚Äô experience, or MS with 15+ years‚Äô experience
• Experience with at least one NDA/CTDs or other regulatory submissions
• Experience representing Statistics function in interactions with regulatory agencies
• Advanced knowledge of clinical study designs, analysis methodology and data interpretation
• Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with the Statistics function
• Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design, analysis of clinical trials and regulatory submissions
• Strong statistical programming skills
• Excellent oral and written communications skills
• Specialized statistical expertise in multiple therapeutic areas or development phases
• Strong interpersonal and people management skills
• Strong project management skills
• Strong collaborative skills and ability to work with a cross-functional team
• Ability to inspire and motivate staff

Skills

• Strong statistical programming skills
• Excellent oral and written communications
• Strong interpersonal and people management
• Strong project management
• Cross-functional collaboration
• Ability to influence and motivate teams

Education

• Desirable higher degree in a scientific discipline with substantial experience (e.g., PhD with 12+ years or MS with 15+ years)