Duke Clinical Research Institute · 22 hours ago
ASSOCIATE DIRECTOR, DCRI
Durham, NC
Full-time
Hybrid
Lead/Staff, Director/Executive
9+ years expDuke Clinical Research Institute is a leading academic medical center dedicated to improving human health through innovative research. The Associate Director of the Interventional Biostatistics team is responsible for managing team operations, ensuring effective statistical services for clinical trial projects, and representing the team in business development efforts. This role involves personnel management, strategic development, and maintaining financial performance while fostering a collaborative team environment.
AssociationBiotechnologyEducationGenetics
Responsibilities
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
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 disciplinary actions, promotions, and transfers of direct reports while providing consultation for management of staff who are supervised by others
Collaborates with Director of Biostatistical Operations and other Biostatistics Associate Directors to ensure consistent employee expectations and treatment across managers within the Biostatistics department
Develops and implements team-specific orientation programs for new employees
Contributes to development of career paths and ongoing training and education of staff
Communicate goals, policies, procedures, and priorities to staff
Monitor forecasts regarding workload volume and make recommendations regarding staffing requirements in order 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 operations of the Biostatistics group, for external clients in the pharmaceutical, medical device, biotechnology, or regulatory community
Raises internal awareness and understanding within DCRI faculty and staff of product line(s) and value to the DCRI
Develops and/or provides input into marketing materials (slide presentations, brochures, website materials) regarding statistical capabilities and services related to product line
Consults with Business Development to provide advice regarding the practicality and appropriateness of potential projects
In collaboration with the Director of Biostatistical Operations, develops goals and objectives on an annual basis, and ensures alignment with the mission, vision, and goals of the DCRI
Assists in developing strategic plans for the future direction of the group to ensure DCRI’s continued position as a leading ARO
Keeps abreast of emerging developments and trends in the field of clinical biostatistics, with special focus within the product line
Provides operational guidance and support to the department toward DCRI’s mission of conducting innovative clinical research
Facilitates the identification and development of new services to be offered by the functional group in order to meet customer needs
Maintain expected financial projections, report/escalate projects at risk, and work within Biostatistics and across functional groups to make changes where necessary
Provide input into budgetary forecasts for functional group expenses (operating and capital) on an annual basis in collaboration with Biostatistics Leadership
Ensure appropriate utilization of resources and adherence to targets
Utilize DCRI tools to oversee financial aspects of projects and work with the respective teams to understand any concerns or areas that need attention
Serve as an expert on internal or external groups to develop policies or guidance documents related to the product line
From time to time, serve as thought leader and provide expertise for research projects conducted by DCRI
Related to product line, develops educational materials, conducts educational programs, and provides mentorship for others, including internal staff and external groups such as pharmaceutical companies and other academic centers, non-statistical staff at the DCRI, and web-based seminars
Serves as a resource within the department on guidelines from the FDA, ICH, EMEA, IRBs, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical data related to area of product focus
Shares solid understanding of clinical research and the clinical drug and/or device development process and maintains this evolving knowledge base into the future
Provides statistical leadership for all assigned team projects with regard to statistical analysis and participation in multi-center clinical trials and projects primarily within product line
Partner with other functions to create strategies for assigned projects
Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions
Proposes novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results within product line. Determines the need for development of novel statistical methodology
Qualification
Required
Bachelor's degree required
Nine years of relevant experience to include 4 years in leadership roles
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Excellent interpersonal, communication, collaborative, and presentation skills
Familiarity with a range of statistical software (e.g., R, SAS, NQuery, EAST, PASS) with fluency in a core language such as R or SAS
Strong statistical knowledge and analytical skills
Experience with safety data, randomization schemes, Data Monitoring Committees and working with the NIH
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 and statistical issues as they pertain to the operations and analyses of clinical trials
Preferred
Master's or doctoral degree in biostatistics, statistics, or a related field
At least two years of experience serving as a statistician on clinical trials
A demonstrated record of progressively responsible roles in academic and/or industry settings
Company
Duke Clinical Research Institute
As part of the Duke University School of Medicine, the Duke Clinical Research Institute is known for conducting groundbreaking.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Jennifer Gloc
Program Manager, Industry Partnerships & Strategic Programs
Srini Depu
SENIOR ANALYST, IT - MICROSOFT POWER APPS DEVELOPER
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