School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nations 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 teams expertise and ensuring that deliverables meet partner expectations.
Responsibilities • Advance the Interventional Biostatistics product line • Mentor team members • Engage 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 • Ensure effective management and oversight for the portfolio • Ensure risk, quality, scope, budget, and timelines are managed for the portfolio • Act as a business partner with other DCRI/Duke groups, etc. • Take a leading role in developing and maintaining standard operating procedures related to product lines • Identify operational problems, issues, obstacles, and barriers across projects that include targeted product lines; identify trends and take corrective actions and implement improvements • Participate in DCRI-wide initiatives and meetings • Understand and proactively remain 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 • Demonstrate a solid understanding of the clinical drug and/or device development process, and maintain this evolving knowledge base into the future • Ensure 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 • Partner 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 participate in the recruitment process for the broader Biostatistics group • Manage staff performance: job descriptions, performance plans, coaching and feedback, performance evaluations, and development plans • Handle coaching and disciplinary actions, promotions, and transfers of direct reports while providing consultation for management of staff who are supervised by others • Collaborate with Director of Biostatistical Operations and other Biostatistics Associate Directors to ensure consistent employee expectations and treatment across managers within the Biostatistics department • Develop and implement team-specific orientation programs for new employees • Contribute 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
Business Development • Lead development and enhancements of the Interventional Biostatistics product line within Biostatistics • Provide consultation and assistance as needed to assist in recruitment and budgeting of new DCRI trial/projects • Represent 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 • Raise internal awareness and understanding within DCRI faculty and staff of product line(s) and value to the DCRI • Develop and/or provide input into marketing materials (slide presentations, brochures, website materials) regarding statistical capabilities and services related to product line • Consult with Business Development to provide advice regarding the practicality and appropriateness of potential projects
Strategic Development • In collaboration with the Director of Biostatistical Operations, develop goals and objectives on an annual basis, and ensure alignment with the mission, vision, and goals of the DCRI • Assist in developing strategic plans for the future direction of the group to ensure DCRIs continued position as a leading ARO • Keep abreast of emerging developments and trends in the field of clinical biostatistics, with special focus within the product line • Provide operational guidance and support to the department toward DCRIs mission of conducting innovative clinical research • Facilitate the identification and development of new services to be offered by the functional group in order to meet customer needs
Financial Management • 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
Sharing Knowledge and Serving as Resource • 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, develop educational materials, conduct educational programs, and provide 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
Statistical Analysis and Contribution to Clinical Research Projects • Provide 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 • Propose novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results within product line • Determine the need for development of novel statistical methodology
REQUIREMENTS AND SPECIFICATIONS
Education/Experience Bachelor's degree required and nine years of relevant experience to include 4 years in leadership roles. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Preferred Qualifications: Master's or doctoral degree in biostatistics, statistics, or a related field, with at least two years of experience serving as a statistician on clinical trials, and a demonstrated record of progressively responsible roles in academic and/or industry settings.
Knowledge, Skills and Abilities • 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
Registration, Certification or Licensure None required
Working Conditions This position is conducted in a professional office working environment or remotely. Occasional night or weekend work may be required depending on the demands of the given research task. This work may require some on-site work at the DCRI for personnel management, sponsor engagements, and other duties best conducted in person.
Minimum Qualifications Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individuals age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy-related conditions), sexual orientation or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these