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. Work may include clinical trials, patient safety, and global medical affairs, collaborating with experts across disciplines to advance medicines to patients. This is an office-based role with hybrid scheduling at 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 and drive alignment with functional management. Partner with Clinical, Regulatory, Patient Safety, GMA, and other functions to develop strategies for assigned projects.
• Demonstrate extensive understanding of statistical concepts and methodologies. Propose novel statistical approaches to study design and provide detail for programming. Ensure analyses comply with protocols and analysis plans.
• Train and mentor staff on statistical methodology and operations. May supervise contract or junior statisticians. Recruit and develop staff training opportunities.
• Develop strategy for data presentation and inference. Ensure interpretation of deliverables in collaboration with other functions. Collaborate on publications and ensure accuracy of reports and publications.
• Act as liaison for statistical issues on collaborative studies with CROs, academic institutions, government agencies, and partners. Build external scientific connections to promote departmental reputation.
• Ensure regulatory requirements are met. Review regulatory submission documents. Engage 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 (10+ years) or PhD (6+ years) in Statistics, Biostatistics, or related field.
• High technical competence and excellent oral and written communication skills.
• Ability to identify data or analytical issues and provide solutions; capable of managing project timelines and deliverables.
• Ability to build strong cross-functional relationships; motivated to drive innovation and challenge the status quo.
• Strong leadership skills with 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 RWE study design, descriptive/inferential statistics, modeling, and programming. Knowledge of methods for confounding control and bias minimization in observational studies preferred.