Associate Director, Safety Statistics; On-site IL or CA

Job Description

Associate Director, Statistics provides statistical leadership for clinical development and life‑cycle management strategies for assigned projects. This role includes responsibilities across clinical trials, patient safety, and global medical affairs, working in partnership with experts in multiple disciplines to bring medicines to patients.

• Lead regulatory submission and product life‑cycle management strategy planning and implementation for assigned projects, including design, analysis, and reporting for clinical or other scientific research programs. Independently develop protocols and statistical analysis plans.
• Represent the statistics function on project teams, providing statistical input for compound/drug development and aligning with functional management. Partner with Clinical, Regulatory, Patient Safety, or GMA to develop strategies for assigned projects.
• Demonstrate extensive understanding of statistical concepts and methodology, proposing novel approaches to study design and ensuring proper implementation in programming. Ensure all statistical analyses specified in protocols and plans are conducted appropriately.
• Train and mentor staff on statistical methodology and operations, supervising contract statisticians or junior statisticians, and assisting functional leaders in recruiting qualified personnel and arranging training opportunities.
• Develop strategies for data presentation and inference, ensuring appropriate interpretation of statistical deliverables and collaborating in publication of scientific research. Ensure accuracy and internal consistency of reports, including tables, listings, and figures.
• Act as liaison for statistical issues on Abb Vie collaborative studies with CROs, academic institutions, government agencies, steering and/or data monitoring committees, joint ventures, or licensing collaborators, fostering external scientific connections.
• Ensure regulatory compliance for work processes, review regulatory submission documents, and participate in discussions with regulatory agencies as needed. Validate external statistical software to ensure compliance with SOPs and regulatory requirements.
• Lead statistical support for benefit‑risk planning and assessment, developing and interpreting safety outputs, including graphics, and addressing pre‑planned and ad‑hoc safety analyses.
• Lead within the Safety Statistics Group to implement initiatives that improve safety data interpretation, monitoring, assessment, and reporting, enhancing consistency across therapeutic areas.
• Support or lead the GMA Statistics group in partnership with GMA, Clinical Research, and Clinical Statistics to develop scientifically appropriate strategies for evidence generation, including GMA studies, presentations, and publications in the assigned therapeutic area(s); provide functional area input for life‑cycle management of products and facilitate communication between product teams and functional management.

• MS (10+ years of experience) or PhD (6+ years of experience) in Statistics, Biostatistics, or a highly related field.
• High degree of technical competence and excellent oral and written communication skills.
• Ability to identify data or analytical issues and provide solutions using own expertise or by seeking assistance.
• Ability to manage project timelines and ensure quality of deliverables.
• Strong relationship‑building skills with peers and cross‑functional partners to drive performance and innovation.
• Leadership experience managing cross‑cultural or overseas teams.
• Pharmaceutical or related industry knowledge with experience in drug development and life‑cycle management within a regulated environment.
• Experience leading safety‑related projects (e.g., benefit‑risk assessment, signal detection).
• Competence in experimental and real‑world evidence study design, descriptive and inferential statistics, statistical modeling, and programming; knowledge of confounding control and bias minimization in observational studies preferred.

• Clinical development experts
• Statistical programmers
• Data science experts
• Patient safety experts
• Global Medical Affairs experts