Statistics Lead, Clinical Development & Submissions

AbbVie; Irvine (CA); On-site; USD 170,000 - 220,000; Full time

Job summary

AbbVie is seeking an Associate Director, Statistics to lead statistical leadership for clinical development and lifecycle management across assigned projects. You will collaborate with clinical, regulatory, patient safety, and GMA teams to advance medicines to patients and ensure robust statistical analyses.

The role requires deep expertise in statistics, strong leadership, and experience managing cross-functional teams in a regulated pharma environment.

Qualifications

• MS with 10+ years or PhD with 6+ years in Statistics/Biostatistics.
• Pharmaceutical knowledge in drug development and regulated environments.
• Strong leadership with experience managing cross-cultural or overseas teams.

Responsibilities

• Provide statistical leadership for design, analysis and reporting of clinical programs.
• Lead regulatory submission strategy and product lifecycle management for assigned projects.
• Collaborate with Clinical, Regulatory, Patient Safety and GMA to develop development strategies.
• Mentor staff on statistical methodology and operations; may supervise contractors.
• Develop data presentation strategy and ensure accurate interpretation of deliverables.

Skills

Statistical leadership

Cross-functional collaboration

Regulatory submissions

Education

MS/PhD in Statistics or Biostatistics

Tools

Job description

AbbVie is seeking an Associate Director, Statistics to lead statistical leadership for clinical development and lifecycle management across assigned projects. You will collaborate with clinical, regulatory, patient safety, and GMA teams to advance medicines to patients and ensure robust statistical analyses.

The role requires deep expertise in statistics, strong leadership, and experience managing cross-functional teams in a regulated pharma environment.