Associate Director, Statistics

About This Role

This role involves providing statistical leadership for clinical development and life-cycle management strategies within assigned projects, including clinical trials, patient safety, and global medical affairs. The Associate Director partners with multidisciplinary experts to advance medicines.

Responsibilities

• Provide expertise/lead regulatory submission and product life-cycle management strategy planning and implementation for assigned projects
• Provide statistical leadership for design, analysis and reporting for clinical or other scientific research programs
• Independently develop protocols and statistical analysis plans
• Represent function/department on project team(s) to provide statistical input to compound/drug development
• Partner with other functions (Clinical, Regulatory, Patient Safety, or GMA) to create development strategies for assigned projects
• Propose novel statistical methodological approaches to design of scientific studies
• Ensure all statistical analyses specified in scientific protocols and analysis plans are conducted appropriately
• Train and mentor staff on statistical methodology and operations
• Develop strategy for data presentation and inference
• 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

Requirements

• MS (with 10+ years of experience) or PhD (with 6+ years of experience) in Statistics, Biostatistics, or a highly related field
• 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
• Able to manage project timeline and quality of deliverables
• Able to build strong relationship with peers and cross-functional partners
• 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

Qualifications

• MS or PhD in Statistics, Biostatistics, or a highly related field
• MS with 10+ years of experience OR PhD with 6+ years of experience in Statistics, Biostatistics, or a highly related field. Pharmaceutical or related industry knowledge required.

Nice to Have

• Experience leading safety-related projects (eg, ISS, benefit-risk assessment, signal detection)
• Competence in experimental and RWE study design, descriptive statistics, inferential statistics, statistical modeling, and statistical programming
• Knowledge of methodologies for confounding control and bias minimization in observational studies preferred

Skills

* Required skills

Benefits