Associate Director, Biostatistics Dcri

Position Summary

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

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

NOTE:

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 or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut.

While this role may have an opportunity to work remotely, the expectation is for an in‑office presence when needed for team meetings, stakeholder engagements, and key leadership activities.

• Ensures effective management and oversight for the portfolio.
• Ensures risk, quality, scope, budget, and timelines are managed 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, issues, obstacles, and barriers across projects, identifies trends, takes corrective actions, and implements improvement.
• Participates in DCRI‑wide initiatives and meetings.
• Understands and proactively remains abreast of guidelines from the FDA, NIH, ICH, EMEA, IRB, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical trial and DSMB data.
• Demonstrates a solid understanding of the clinical drug and/or device development process, and maintains this evolving knowledge base into the future.
• Ensures that sample size estimates for proposals are conducted, mostly working with a faculty member.
• Support or lead communications between assigned product team(s) and functional management. Build/drive cross‑functional relationships and collaboration.

• Partners with the Director of Biostatistical Operations, the DCRI Data Science and Biostatistics Therapeutic Area Faculty Director 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 providing consultation for management of staff who are supervised by others.
• 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 recommendations regarding staffing requirements 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 as needed to assist in recruitment and budgeting of new DCRI trial/projects.
• Represents the Biostatistics group in internal and external business development meetings, including presentations about the capabilities and…