School of Medicine:
Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked tenth among its peers, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where traditional barriers are low, interdisciplinary collaboration is embraced, and great ideas accelerate translation of fundamental scientific discoveries to improve humanhealth locally and around the globe.
Comprised of 2,400 faculty physicians and researchers, the Duke University School of Medicine along with the Duke University School of Nursing and Duke University Health System create Duke Health. Duke Health is a world-class health care network. Founded in 1998 to provide efficient, responsive care, the health system offers a full network of health services and encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Private Diagnostic Clinic, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.
Supervises the oversight and/or directs the day-to-day statistical analyses for secondary manuscripts and research analytics projects with the Center for Predictive Medicine. Also provides consultation/analysis for primary manuscripts for clinical trials when needed. This includes:
- Provide statistical expertise to internal and external investigators.
- Hire, manage and mentor members of the Center for Predictive Medicine (CPM).
- Ensure appropriate estimates for time and costs are generated for budgets for those tasks performed by members of the Center for Predictive Medicine (CPM) or other statistical teams.
- Represent DCRI statistics in meetings with sponsors and collaborators.
- Manage the CPM research portfolio.
- Be involved in new business development.
- Oversee the financial status of the CPM portfolio.
- Provide statistical oversight of lead statisticians on projects.
- Ensures appropriate training, mentorship and advancement of team members
Reviews and comments on analysis work products and manuscripts. Develops educational materials for different audiences, for those with a minimal understanding of statistics to those with advanced statistical knowledge. Develops new understanding of statistical and data science methods as they are developed and mentors lead statisticians on using these methods. Shares statistical knowledge with others about simple and complex analyses, database merging, and other statistical issues as they arise.
Sharing Knowledge and Serving as Resource
- Develops educational materials, conducts educational programs, and provides mentorship for others, including external groups such as pharmaceutical companies and other academic centers, non-statistical staff at the DCRI, and Web-based seminars
- Provides educational experience/mentorship for internal statistical staff as follows:
- Coordinates educational seminars
- Offers educational opportunities and mentoring for statistical staff to expand their knowledge in the areas of analyses, medical writing, and communication
- Serves as statistical resource for other members of the statistical team for simple and complex analyses, database merging, and other statistical or programming issues.
- Learns about new statistical methods and shares the statistical concepts with others
- Serves as the statistical liaison and consultant for national and international publication committee meetings
- In addition to answering general questions, advises on such issues as they relate to manuscripts, patient-specific datasets, and receiving such datasets.
Statistical Analysis and Contribution to Clinical Research Projects
- Serves consistently at the level of Senior Statistician and/or Principal Statistician with regard to statistical analysis on CPM projects
- Is sought after as a key project participant
- Retains primary responsibility of own analyses and projects in order to stay in touch with new experiences encountered by CPM staff facing similar problems within product line
- Mentors and interprets advanced statistical analysis
- Reviews the statistical literature and shares most relevant methods.
- Provides statistical consulting for external investigators who have collected their own data.
- Oversees recruitment and hiring of statistical staff within CPM, and participates in the recruitment process for the broader Statistics group
- Handles coaching and disciplinary actions, promotions, and transfers of direct reports.
- Provide consultation for management of staff who are supervised by others in CPM.
- Collaborates with Faculty Director of CPM, and FG Director and other Associate Directors to ensure consistent employee expectations and treatment across managers within the Statistics Department
- Develops and implements CPM-specific orientation programs for new employees
- Contributes to development of career paths and ongoing training and education of all Statistics staff
- Maintains clearly defined job descriptions and competency matrix
- Manages staff performance: performance plans, coaching and feedback, performance evaluations, and development plans
- Communicates goals, policies, procedures, and priorities to staff within CPM
- Monitors forecasts regarding workload volume and makes recommendations regarding staffing requirements in order to fulfill project deliverables while ensuring optimal efficiency and quality
- Manages CPM managers and may manage CPM administrative staff
- Develop or oversee development of workflow and operational processes to maximize standardization of approaches across all projects and achieve optimal efficiency
- Determine and approve situations in which deviations from established processes are appropriate
- Monitor progress and performance of clinical projects on an ongoing basis and ensure that services performed are in compliance with regulatory requirements and quality standards and within budgetary limits
- Identify operational problems, issues, obstacles, and barriers across projects; identify trends and make recommendations for improvement
- Oversee appropriate quality control activities
- Acts as a liaison to operations staff throughout DCRI
- In partnership with the CPM Faculty Director, provide consultation and assistance to the functional group director in developing 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 functional group.
- In partnership with the CPM Faculty Director, develop goals and objectives for CPM on an annual basis, ensuring alignment with the goals and objectives of the statistics functional group.
- Keep abreast with emerging developments and trends in the field of clinical biostatistics
- Provide operational guidance and support to the department toward DCRI’s mission of conducting innovative clinical research
- Facilitate the identification and development of new services to be offered by CPM in order to meet customer needs
- In partnership with the CPM Faculty Director, leads development and enhancements of the CPM product lines (Secondary Manuscript and Research Analytics) within the Biostatistics functional area
- Provides consultation and assistance to the Faculty Directors of CPM and Statistics, Associate Director for Business Operations, and Administrative and Budgeting Coordinator as needed to assist in recruitment and budgeting of new projects
- Raises internal awareness and understanding within DCRI faculty and staff of CPM
- Develops and/or provides input into marketing materials (slide presentations, brochures, website materials) regarding statistical capabilities and services related to product line
- Consults with Strategic Business Development to provide advice regarding the practicality and appropriateness of potential projects
- Collaborates closely with the Administrative and Budgeting Coordinator when needed to assist in proposal development and project budgeting
EDUCATION, EXPERIENCE, AND SKILLS
Master’s or Doctoral degree in (bio)statistics or related field highly preferred, and at least 8 (preferably 10 or more) years’ experience as a statistician in clinical research, with previous personnel management and supervisory experience..
Knowledge, Skills, and Abilities include:
- Excellent interpersonal, communication, and presentation skills
- Advanced knowledge of SAS software as well as other statistical software (examples: R, Python),
- Advanced statistical knowledge and analytical skills
- Excellent organizational skills, demonstrated ability to lead in a team environment, and an ability to supervise and delegate tasks
- Excellent working knowledge of clinical issues as they pertain to statistical analyses
- Familiarity with data science methods
- Experience with version control, databases, distributed computing, or cloud computing is preferable but not required.
- Intellectual curiosity, as demonstrated by proactive pursuit of learning opportunities and diverse, challenging projects.
Reports to the Faculty Director of the Center for Predictive Medicine at the DCRI.
Bachelor's degree required, preferably in nursing, pharmacy, or other allied health care discipline; Prefer Master's degree or other post graduate training in a clinical discipline or business/health care administration
Minimum of 8 years in clinical research. Previous personnel management
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE and supervisory experience.
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