Associate Director, Dcri

Overview

Duke University School of Medicine, established in 1930, is the youngest of the nation's top medical schools. Ranked sixth among medical schools, the school embraces an inclusive community of outstanding learners, investigators, clinicians and staff where interdisciplinary collaboration accelerates translation of scientific discoveries to improve human health locally and globally.

The Associate Director of the Interventional Biostatistics team manages team operations, including personnel management, quality assurance, resource planning and financial performance. The role ensures delivery of effective statistical services for interventional clinical trial projects while cultivating a collaborative team environment. The Associate Director represents the group in sponsor meetings and business development efforts, showcasing the team's expertise and ensuring deliverables meet partner expectations.

Responsibilities also include advancing the Interventional Biostatistics product line, mentoring team members and engaging in cross‑functional initiatives within DCRI.

This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts:
Arizona, California, Florida, Georgia, Hawaii, Illinois, Maryland, Massachusetts, Montana, New Jersey, New York, North Carolina, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington DC, Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware.

• Ensures effective management and oversight for the portfolio.
• Manages risk, quality, scope, budget and timelines for the portfolio.
• Acts as a business partner with other DCRI/Duke groups.
• Takes a leading role in developing and maintaining standard operating procedures related to product lines.
• Identifies operational problems and implements corrective actions and improvements.
• Participates in DCRI‑wide initiatives and meetings.
• Stays abreast of guidelines from FDA, NIH, ICH, EMEA, IRB, HIPAA and other regulatory agencies as they apply to statistics, programming and handling of clinical trial and DSMB data.
• Maintains a solid understanding of the clinical drug and device development process.
• Ensures sample size estimates for proposals are conducted, primarily working with a faculty member.
• Supports or leads communications between assigned product team(s) and functional management, building cross‑functional relationships and collaboration.

• Partners with the Director of Biostatistical Operations and HR to develop a strategy for recruitment, mentoring and training aligned with DCRI clinical research priorities.
• Oversees recruitment and hiring of statistical staff within the team and participates in the recruitment process for the broader Biostatistics group.
• Manages staff performance: job descriptions, performance plans, coaching and feedback, performance evaluations and development plans.
• Handles coaching and disciplinary actions, promotions and transfers of direct reports while consulting on management of staff supervised by others.
• Collaborates with the Director of Biostatistical Operations and other Biostatistics Associate Directors to ensure consistent employee expectations and treatment across managers.
• Develops and implements team‑specific orientation programs for new employees.
• Contributes to development of career paths and ongoing training and education of staff.
• Communicates goals, policies, procedures and priorities to staff.
• Monitors forecasts regarding workload volume and makes staffing recommendations to fulfill project deliverables while ensuring optimal efficiency and quality.

• Leads development and enhancements of the Interventional Biostatistics product line within Biostatistics.
• Provides consultation and assistance to assist in recruitment and budgeting of new DCRI trial/project.
• Represents the Biostatistics group in internal and external business development meetings, presenting capabilities and operations of the…