Associate Director, Statistics (Hybrid)

Role Summary

Associate Director, Statistics (Hybrid) in Takeda's Statistics and Quantitative Sciences (SQS) leads asset-level strategy and delivery within Global Project Teams, collaborating across DQS and R&D and with external vendors. The role designs efficient clinical trials, oversees high-quality statistical analyses, and drives cross-functional delivery to bring safe and effective medicines to patients. Location: Boston, MA (hybrid).

Responsibilities

• Lead delivery for one or more assets at GPT level or specialty area in clinical
• Facilitate execution and delivery collaboration cross functionally in Global Project Teams (GPTs), generally within DQS and R&D, and with external vendors
• Enable the consistent execution of the SQS and DQS seamless and predictable delivery mission
• Lead and be accountable for asset level delivery strategies being implemented with effective risk identification and mitigation
• Create an internal cross functional and external with vendors sphere of influence in predictable delivery
• Identify opportunity for continuous improvement in delivery approaches and leverages fit-for-purpose mitigations by leveraging them
• Asset-level GPT strategy and delivery
• Broadly DQS functions
• Parts R&D functions
• Lead one or more assets at GPT level or specialty area in preclinical, clinical, translational
• Facilitate collaboration cross functionally in GPTs and generally within DQS and R&D
• Enable the tactical execution of the SQS and DQS vision and mission
• Lead and be accountable for asset level strategies being implemented
• Demonstrate mentorship, matrix or direct management of small team of SQS colleagues
• Create an internal and external sphere of influence in area of expertise

Qualifications

• 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 inter-personal and people management skills.
• Strong project management skills.
• Strong collaborative skills and ability to work with a cross-functional team.

Skills

• Subject matter expertise in several quantitative and statistical areas and establishes oneself as a go-to colleague on a few topics
• Scientific understanding of drug R&D to inform methodological input with product team or in a platform
• Strong communication skills and ability to translate effectively across functional lines
• Ability to Identify and research new innovative approaches and leverage fit-for-purpose methods in to programs that he/she is involved in

Education

• PHD with ~ 5 years experience
• MS with ~ 8+ years experience