Associate Director, Statistics (Office based)

Role Summary

The Associate Director, Statistics - Oncology provides statistical leadership for clinical development and life-cycle management strategies for assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The role works in partnership with experts in multiple disciplines to advance medicines to patients. This is an office-based role with hybrid schedule in select AbbVie locations.

Responsibilities

• Provide statistical support for one or more clinical development projects through own efforts or those of a team. Lead/develop statistical strategy for project development and regulatory submission.
• 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 teams to provide statistical input to drug development and drive alignment with functional management. Partner with other functions to create development strategies for assigned projects.
• Demonstrate extensive understanding of statistical concepts and methodology. Propose novel statistical approaches to study design. Provide detail to allow programming implementation. Ensure all analyses align with protocols and plans.
• Train and mentor staff on statistical methodology and operations. May supervise contract or junior statisticians. Develop expertise in innovative statistical methods and support recruitment and professional development of staff.
• Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables, collaborate on publications, and ensure accuracy and consistency of reports and publications (tables, listings, figures).
• Act as liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, and other partners. Build external scientific connections to foster professional development and the department's reputation.
• Ensure regulatory requirements for work processes are met. Review regulatory submission documents. Participate in discussions with regulatory agencies as needed. Validate external statistical software for SOP and regulatory compliance.
• Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day).

Qualifications

• MS with 10+ years of experience or PhD with 6+ years of experience in Statistics, Biostatistics, or related field.
• High technical competence and excellent oral and written communication skills.
• Able to identify data or analytical issues and provide solutions using own skills or by seeking assistance.
• Able to manage project timelines and deliverable quality.
• Able to build strong relationships with peers and cross-functional partners; motivated to drive innovation and challenge the status quo.
• Strong leadership skills and experience managing cross-cultural or overseas teams.
• Pharmaceutical or related industry knowledge, including drug development and lifecycle management in a regulated environment.
• Experience leading safety-related projects (e.g., ISS, benefit-risk assessment, signal detection).
• Competence in experimental and real-world evidence study design, descriptive and inferential statistics, statistical modeling, and programming. Knowledge of methods for confounding control and bias minimization in observational studies preferred.

Skills

• Statistical design and analysis
• Regulatory submission support
• Leadership and mentoring
• Cross-functional collaboration
• Communication of complex statistical concepts