Associate Director, Statistics

Role Summary

The Associate Director, Statistics provides statistical leadership for clinical development and life-cycle management strategies for assigned projects, including areas such as clinical trials, patient safety, and global medical affairs. The role collaborates with experts across disciplines to advance medicines to patients.

Responsibilities

• Provide expertise and 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 (or product safety analysis plans/integrated summary of safety analysis plans/analysis plans for GMA evidence generation).
• Represent the function on project teams to provide statistical input to development and drive alignment with functional management; partner with Clinical, Regulatory, Patient Safety, or GMA to create development strategies for assigned projects.
• Demonstrate extensive understanding of statistical concepts and methodology; propose novel statistical approaches for study design; provide sufficient detail for programming implementation; ensure statistical analyses are conducted as specified.
• Train and mentor staff on statistical methodology and operations; supervise contract or junior statisticians when needed; recruit and develop staff.
• Develop strategy for data presentation and inference; ensure appropriate interpretation of statistical deliverables; collaborate on publications; ensure accuracy and consistency of reports and publications, including Tables, Figures, and Listings.
• 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 department reputation.
• Contribute to evidence generation, including GMA studies, presentations, and publications; provide input for lifecycle management; facilitate communications between product teams and management; build cross-functional relationships.

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.
• Ability to identify data or analytical issues and propose solutions; capable of managing project timelines and deliverables.
• Ability to build strong relationships with peers and cross-functional partners; motivated to drive innovation and challenge 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.