Associate Director, Statistics (Hybrid)

Role Summary

Associate Director, Statistics (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

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 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

Education

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