ASSOCIATE DIRECTOR, BIOSTATISTICS DCRI

Who we are:

The Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, is the largest full-service, mission-driven academic clinical research organization. We combine insights from practicing physicians in a world-class health system with unmatched data science expertise and an end-to-end operations infrastructure. Our model ensures studies and trials of all sizes run effectively, achieve the best outcomes, and transform health care for our patients and people everywhere. For 30 years, the DCRI has partnered with government, industry, and academic collaborators to generate evidence that changes clinical practice. At the DCRI, our values honor our history and guide our actions and daily decisions. Our values and our mission help us define what it means to be successful-as an organization, as individuals, and as a partner to our sponsors. Together, we are making tomorrow better than today-one patient, one question, one innovation at a time.

The Opportunity:

Biostatistics at the Duke Clinical Research Institute is entering an exciting new chapter. As DCRI expands its capabilities in biostatistics, biomedical informatics, and data science, this role offers a unique opportunity to help shape the future scope of clinical research-moving beyond traditional Phase II/III trial support to advance innovative, pragmatic research and AI-enabled discovery. The Associate Director will play a central leadership role in this transformation, helping build a forward-looking biostatistics enterprise known for scientific rigor, methodological innovation, and meaningful impact on human health.

You will lead a team of talented biostatisticians while serving as a strategic leader who helps define what DCRI's biostatistics enterprise can become. We are looking for someone with deep statistical expertise and the leadership instincts to cultivate team science, grow new capabilities, and drive AI integration into research and operations. In two to three years, this person will have built a team recognized not just for study execution, but for innovation and thought leadership - a team that embodies Duke's values of collaboration, inclusion, and scientific rigor, and that sponsors seek out as a strategic partner rather than a technical resource.

This staff role closely collaborates with and supports faculty; it is not intended as a path to a faculty position.

This is a remote-first position, with in-person collaboration in Durham expected a couple of times per month. Duke remote workers must reside in an eligible state

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

Position Summary:

The Associate Director leads the assigned Biostatistics team across operations, performance management, quality, resource planning, and financial performance - with an explicit mandate to advance DCRI's strategy and transformation agenda. This role is a driver of strategic growth in innovative and pragmatic research, a champion of AI and data science integration, and a cultivator of the team science culture that defines Duke's approach to clinical research.

Primary Responsibilities:

Operations Management

• Set the standard for portfolio oversight - leading the team to manage risk, quality, scope, budget, and timelines across all assigned projects.
• Build and sustain strong partnerships with DCRI and Duke leaders and their teams, acting as a collaborative bridge across the organization and its data science and informatics initiatives.
• Own the development and maintenance of standard operating procedures; identify trends and systemic issues across the portfolio and empower the team to implement preventative and corrective actions.
• Stay current on evolving FDA, NIH, ICH, EMEA, IRB, and HIPAA guidance and educate and inform the team; maintain and advance expertise in the clinical drug and device development process.
• Provide fluency in the clinical drug and/or device development process and business needs of our industry, federal and other research sponsors.
• Ensure rigorous science in close collaboration with clinical and quantitative faculty.

Personnel Management

• Build a forward-looking talent strategy - recruiting for diverse methodological backgrounds and the skills needed for AI-era clinical research, not just traditional trial expertise.
• Develop a high-performing, collaborative team through clear expectations, meaningful coaching, advocacy and development planning grounded in Duke's values of team science and inclusion.
• Design onboarding and continuous engagement practices that orients remote staff to DCRI's culture and evolving data science mission; co-create career pathways that prepare staff for a field being reshaped by AI and informatics.
• Set and enable high-performance standards by coaching staff toward clear expectations, consistent accountability, professional growth, and sustained excellence; address underperformance through appropriate employee actions; and monitor workload forecasts and make timely staffing changes to ensure utilization aligns with priorities.

Business Development

• Champion DCRI Biostatistics services - developing its offerings, sharpening its value proposition, and positioning it for growth in innovative and pragmatic research.
• Represent the Biostatistics group in sponsor and partner meetings; contribute to proposals, budgets, and marketing materials that reflect the group's capabilities and growing leadership in data science and AI.
• Advise Business Development and principal investigators on the feasibility and fit of potential projects; raise internal awareness of our capabilities and value across DCRI faculty and staff.

Strategic Development and Innovation

• Drive DCRI's transformation from within - actively advancing AI integration, expanding capabilities in innovative and pragmatic trial designs, and providing leadership to DCRI's data-centric strategic priorities.
• Model and cultivate team science: breaking down silos, fostering cross-functional collaboration with biomedical informatics and data science, and positioning biostatistics as integral to DCRI's broader scientific community.
• Co-develop annual goals with DCRI functional group leaders and peers aligned with DCRI's mission; contribute to long-term strategic planning that positions the group for the next era of clinical research.
• Stay at the forefront of the field - tracking AI/ML, real-world evidence, adaptive designs, and informatics developments - and translate that knowledge into direction for the team and new service offerings.
• Contribute to DCRI's external reputation through publications, presentations, and partnerships that reflect the group's evolving capabilities and thought leadership.

Financial Management

• Maintain financial transparency across the portfolio - tracking projections, surfacing risks early, and working across functions to course-correct when needed.
• Contribute to annual budgetary forecasting; drive efficient resource utilization and ensure the team operates within established financial targets.

Knowledge Sharing and Statistical Leadership

• Serve as a recognized expert and thought leader - contributing to policy and guidance development, educational programs, and mentorship for internal staff and external partners.
• Provide hands-on statistical leadership for assigned projects, including multi-center clinical trials; propose novel approaches - including AI and data science methods - that improve study efficiency and rigor.
• Guide the team in sound data presentation and inference strategies; ensure statistical deliverables are interpreted correctly and compellingly across functions.

Other Duties

• Performs other related duties incidental to the work described herein.

Required Qualifications

Education/Experience:

• Position requires a minimum of a bachelor's degree, nine years of relevant experience to include 4 years in leadership roles

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

• A Master's or Doctoral degree in (bio) statistics or related field and at least 9 (preferably 10 or more) years of experience as a statistician, with at least 2 years of experience working on clinical trials, with progressively more responsible positions in academia and/or the pharmaceutical, medical device, or biotechnology industries Highly preferred.

Knowledge, Skills and Abilities:

• Excellent interpersonal, communication, collaborative, and presentation skills.
• Familiarity with a range of statistical software with fluency in a core language such as SAS and R and operating in experience developing and maintaining reproducible code using version control tools such as Subversion or Git.
• Strong statistical knowledge and analytical skills.
• Experience with CDISC standards, safety data, dynamic randomization schemes, platform trials, Data Monitoring Committees and data sharing repositories.
• Excellent organizational skills demonstrated ability to lead in a team environment, and an ability to supervise and delegate tasks.
• Excellent working knowledge of clinical, operational, statistical and data operations issues as they pertain to the operations and analyses of clinical trials.