Sr. Director, Statistics

Role Summary

Senior leadership role in Statistics within Takeda's R&D Data & Quantitative Sciences, responsible for execution and delivery leadership across Therapeutic Area Units, Business Units, or SQS functions. Drives seamless and predictable R&D delivery, identifies risks and mitigation strategies, and develops delivery capabilities through processes and oversight. Represents statistics with vendors and partners and provides strategic vision for 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

• Education & Competencies (Technical and Behavioral): Desired education qualifications and equivalencies (e.g., PhD degree in a scientific discipline with 12+ years’ experience, or MS with 15+ years’ 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 skills
• 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

Education

• PhD in a scientific discipline with 12+ years’ experience, or MS with 15+ years’ experience