Associate Director, Statistics — Clinical Development

AbbVie; North Chicago (IL); On-site; USD 170,000 - 210,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401(k) plan

Job summary

AbbVie in Illinois is seeking an Associate Director of Statistics to lead statistical strategy for clinical development and lifecycle management across projects, partnering with clinical, regulatory, safety and medical affairs teams.

The role emphasizes trial design, analysis plans, regulatory submissions, data presentation, and mentorship of staff, with opportunities to influence global programs and external collaborations.

Qualifications

• MS (with 10+ years) or PhD (with 6+ years) in Statistics, Biostatistics, or a highly related field.
• Have strong leadership skills and experience in working/managing cross-cultural or oversea teams.
• Pharmaceutical or related industry knowledge required, including experience and understanding of drug development and life-cycle management in the regulated environment.
• PhD preferred
• Submission experience preferred
• High degree of technical competence and excellent communication skills, both oral and written
• Able to identify data or analytical issues, and assist with providing solutions by either applying own skills and knowledge or seeking help from others
• Able to manage project timeline and quality of deliverables
• Able to build strong relationship with peers and cross-functional partners to achieve higher performance. Highly motivated to drive innovation by raising the bar and challenging the status quo

Responsibilities

• Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects.
• Represent function/department on project team(s) to provide statistical input to compound/drug development and drive alignment with functional management.
• Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical methodological approaches to design of scientific studies.
• Train and mentor staff on statistical methodology and operations. May supervise contract statisticians or junior statisticians.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions.
• Act as the liaison for statistical issues on AbbVie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures or licensing collaborators.
• Ensure that all applicable regulatory requirements for work processes are met. Critically review regulatory submission documents.

Skills

Statistical leadership

Cross-functional leadership

Biostatistics

Drug development

Regulatory submissions

Education

MS in Statistics/ Biostatistics

PhD in related field

Job description

AbbVie in Illinois is seeking an Associate Director of Statistics to lead statistical strategy for clinical development and lifecycle management across projects, partnering with clinical, regulatory, safety and medical affairs teams.

The role emphasizes trial design, analysis plans, regulatory submissions, data presentation, and mentorship of staff, with opportunities to influence global programs and external collaborations.