Associate Director, Statistics (Hybrid)

AbbVie•Irvine, CA

9d•$141,500 - $268,500•Hybrid

About The Position

The Associate Director, Statistics 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. The role partners with experts across multiple disciplines to advance medicines to patients. The position leads statistical strategy and provides leadership for study design, analysis, reporting, and regulatory submissions. It represents Statistics on project teams, develops protocols and statistical analysis plans, supports cross-functional development strategies, and ensures appropriate conduct and interpretation of analyses. The role also mentors staff, collaborates on scientific publications, liaises with external collaborators, and helps ensure statistical work meets regulatory requirements.

Requirements

MS in Statistics, Biostatistics, or a highly related field with at least 10 years of experience, or PhD in those fields with at least 6 years of experience.
Demonstrated depth in statistical methodology and practical application, including judgment to identify complex data, design, or analytical issues and develop effective solutions.
Excellent written and oral communication skills, including explaining complex statistical concepts and recommendations to technical and nontechnical audiences.
Ability to independently lead work across competing priorities, manage project timelines, and deliver high-quality, fit-for-purpose outputs.
Ability to build strong relationships with peers and cross-functional partners and drive innovation by challenging the status quo.
Strong leadership skills and experience working with or managing cross-cultural or overseas teams.
Pharmaceutical or related industry knowledge, including experience and understanding of drug development and life-cycle management in a regulated environment.
Clinical trial experience.

Nice To Haves

Immunology clinical trial experience.
PhD in statistics or biostatistics.

Responsibilities

Provide statistical support for one or more clinical development projects, personally or through a team, and lead or develop statistical strategy for project development and regulatory submissions.
Lead the design, analysis, and reporting of clinical or other scientific research programs; independently develop protocols and statistical analysis plans.
Represent the Statistics function on project teams, contribute to compound and drug development, and partner with Clinical, Regulatory, Patient Safety, and Global Medical Affairs on development strategies.
Apply statistical concepts and methodology, propose novel approaches to study design, specify details for programming implementation, and ensure analyses are conducted appropriately.
Train and mentor staff on statistical methodology and operations; may supervise contract or junior statisticians; assist with recruiting and arranging staff training and professional development.
Develop strategies for data presentation and inference, ensure appropriate interpretation of statistical deliverables, collaborate on scientific publications, and ensure accuracy and consistency of reports and publications, including tables, listings, and figures.
Act as the statistical liaison for collaborative studies with CROs, academic institutions, government agencies, steering or data monitoring committees, joint ventures, and licensing collaborators; build external scientific connections.
Ensure applicable regulatory requirements are met, critically review regulatory submission documents, participate in discussions with regulatory agencies as needed, and validate external statistical software for SOP and regulatory compliance.