Associate Director, Statistics (Hybrid)

Role Summary

Associate Director, Statistics (Hybrid) at AbbVie. This role is hybrid on-site with local candidates in Lake County, IL or Florham Park, NJ. The position entails leading statistical expertise within Medical Affairs & Health Technology Assessment (MAHTA) Statistics, partnering across MHI, iMAP, and other functions to provide statistical leadership for drug development, life-cycle management, and HTA/submission activities.

Responsibilities

• Provide scientific and statistical expertise for drug development and life-cycle management, including design, analysis, and reporting of clinical and other scientific programs; generate evidence to support medical affairs strategies; interact with regulatory agencies, the medical community, and KOLs regarding results.
• Direct development of scientific protocols ensuring they are scientifically sound, aligned with product strategy, and meet regulatory needs; ensure appropriate statistical methodology.
• Lead the introduction of new statistical methods into analysis plans and communicate statistical concepts to non-statisticians.
• Review technical or data-related issues in design, conduct, or analysis of trials or research; select and implement alternative analysis strategies; assess software and development needs for novel methodologies.
• Maintain and expand technical skills; present statistical research at meetings; uphold Statistics department standards, GxP compliance, and best practices.
• Collaborate with MHI, Clinical Statistics, Data Sciences, and others to evaluate databases, conduct feasibility assessments, and develop detailed analysis plans for evidence generation to inform decisions.
• Evaluate alternatives to RCTs using real-world data sources (EHRs, claims, registries) when appropriate.
• Play a key role in cross-functional teams to ensure scientifically sound results and timely, high-quality statistical deliverables; provide in-depth statistical reviews for reports/publications.
• Support/Lead HTA submissions for reimbursement and lifecycle management; develop protocols and analysis plans to address evidence gaps.

Qualifications

• MS (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or related field.
• Strong technical and communication skills (oral and written).
• Experience in experimental and RWE study design, descriptive/inferential statistics, modeling, and programming; knowledge of confounding control and bias minimization in observational studies preferred.
• Ability to identify issues and propose solutions; build cross-functional relationships; drive innovation.
• Willingness to learn new knowledge and technologies; proactive and self-starting.
• Strong leadership and experience managing a programming group; experience with cross-cultural or international teams.
• Pharmaceutical or related industry experience, including drug development and lifecycle management in a regulated environment.
• Ability to rapidly grasp core concepts and adjust direction as needed.

Skills

• Statistical modeling
• RWE study design
• Observational study methodologies
• Data interpretation and communication to non-statisticians
• Cross-functional collaboration
• Regulatory and HTA knowledge

Education

• MS or PhD in Statistics, Biostatistics, or related field.

Additional Requirements

• Hybrid work arrangement; must be local to Lake County, IL or Florham Park, NJ.