Associate Director, Statistics (Hybrid)

Role Summary

Associate Director, Statistics (Hybrid) at Takeda. Lead delivery for assets within clinical and cross-functional collaboration to enable consistent, predictable delivery; contribute to asset-level strategies and continuous delivery improvements; mentor and lead SQS colleagues as part of a cross-functional team.

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

Qualifications

• Education: PhD with ~5 years experience; MS with ~8+ years experience

Skills

• Advanced knowledge of clinical study designs, analysis methodology and data interpretation
• Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in 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
• 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 into programs
• Leadership: mentor and potentially manage small team of SQS colleagues; lead assets at GPT level

Education

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

Additional Requirements

• Location: Boston, MA
• Time Type: Full time
• Job Exempt: Yes