Associate Director, Statistics

Role Summary

The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects, including areas such as clinical trials, patient safety, and global medical affairs. The role collaborates with experts across disciplines to advance medicines to patients.

Responsibilities

• Provide expertise and lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects. Lead design, analysis and reporting for clinical or other scientific programs; independently develop protocols and statistical analysis plans.
• Represent the function on project teams to provide statistical input and align with functional management; partner with Clinical, Regulatory, Patient Safety, and GMA to create development strategies.
• Demonstrate extensive understanding of statistical concepts; propose novel methodological approaches; ensure analyses follow protocols and analysis plans; provide detailed guidance for programming implementation.
• Train and mentor staff on statistical methodology; may supervise contract or junior statisticians; recruit and arrange professional development opportunities.
• Develop strategy for data presentation and inference; ensure interpretation of statistical deliverables; collaborate on publications; ensure accuracy and consistency of reports, tables, listings, and figures.
• Act as liaison for statistical issues on AbbVie collaborative studies; build external scientific connections to foster professional development and promote the Statistics department.
• Ensure regulatory requirements for work processes are met; review regulatory submission documents; participate in discussions with regulatory agencies; validate external statistical software for compliance.
• This is a hybrid position with location options: Lake County, IL; San Francisco, CA; Irvine, CA; Florham Park, NJ.

Qualifications

• MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or related field.
• High technical competence and excellent oral and written communication skills.
• Ability to identify data or analytical issues and provide solutions; capable of managing project timelines and deliverables.
• Strong relationship-building with peers and cross-functional partners; motivated to drive innovation and challenge the status quo.
• Leadership experience with cross-cultural or overseas teams.
• Pharmaceutical or related industry knowledge, including drug development and life-cycle management in a regulated environment.