ASSOCIATE DIRECTOR, DCRI

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

DCRI POSITION DESCRIPTION

 

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. 

 

Primary Responsibilities and Tasks

 

Operations Management

• 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 etc.
• Takes a leading role in developing and maintaining standard operating
  procedures related to product lines.
• Identifies operational problems, issues, obstacles, and barriers across
  projects that include targeted product line; identify trends and 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.

Personnel Management

 

• 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 that is aligned with DCRI clinical research priorities.
  Oversee 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 d