Statistics Lead, Clinical Development & Lifecycle Strategy

AbbVie; South San Francisco (CA); On-site; USD 150,000 - 200,000; Full time

Benefits offered by this job

Long-term incentives

401(k) plan

Job summary

AbbVie is seeking an Associate Director of Statistics to provide statistical leadership for clinical development and lifecycle management strategies across assigned projects. The role partners with multidisciplinary teams to advance medicines while ensuring regulatory compliance and robust statistical analyses are performed.

You will guide design, analysis, and reporting, mentor junior statisticians, and help recruit talent.

Qualifications

• MS (with 10+ years of experience) or PhD (with 6+ years of experience) 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.

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.

Job description

AbbVie is seeking an Associate Director of Statistics to provide statistical leadership for clinical development and lifecycle management strategies across assigned projects. The role partners with multidisciplinary teams to advance medicines while ensuring regulatory compliance and robust statistical analyses are performed.

You will guide design, analysis, and reporting, mentor junior statisticians, and help recruit talent.