ASSOCIATE DIRECTOR, DCRI, Statistics, Observational Research (HSR/CPM/Outcomes)

*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.

*Occupational Summary*
Oversee and direct operations, personnel management, financial performance, information systems, quality improvement, and strategic planning of the Observational Research group. Partner with the Director of Statistical Operations and the DCRI Statistics Therapeutic Area Faculty Director to: (1) Develop and implement strategies to enhance the performance and capabilities of DCRI's Observational Research statistical services and ensure the alignment of group goals and objectives with the mission, vision, and goals of the DCRI. (2) Oversee the development of operational plans and monitor the progress and performance of statistical services for all group projects; to include service quality, data integrity, and timeliness of deliverables. (3) Ensure appropriate recruitment, mentoring and training of non-faculty statisticians. This work may require some on site work at the DCRI for personnel management, sponsor engagements, and other duties best conducted in person.

Most DCRI positions can be done remotely for candidates who live in the following states: NC, CA, FL, GA, MD, NY, SC, TN, TX, VA, and District of Columbia (DC), Arizona, Hawaii, Illinois, Montana.

*Work Performed*

Operations Management/ Business Development

* Oversee or develop 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 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 takes corrective actions and implements improvement. Oversee appropriate quality control activities.
* Serve as a liaison with the statistical faculty of the DCRI to ensure that the activities of the non-faculty statisticians are appropriately coordinated with the faculty.
* Keep abreast of emerging technologies and their potential application to statistical activities. Identify and make recommendations regarding the acquisition and development of new information systems (including software and hardware) needed to support statistical operations.
* Represent Statistics in grant proposals, sales presentations, and other interactions with sponsors. Provide input into marketing and sales materials (slide presentations, brochures, etc.) regarding statistical capabilities and services.
* Provide input in the development, use, and revision of cost standards for statistical services in the pricing model.
* Ensure appropriate utilization of resources and adherence to utilization targets.

*Personnel Management *

* Partners with the Director of Statistical Operations, the DCRI Statistics Therapeutic Area Faculty Director and HR to develop a strategy for recruitment, mentoring and training that is aligned with DCRI clinical research priorities.
* Oversees recruitment and hiring of statistical staff within unit, and participates in the recruitment process for the broader Statistics 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 Statistical Operations and other Associate Directors to ensure consistent employee expectations and treatment across managers within the Statistics Department.
* Develops and implements unit-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.

*Strategic Development *

* In collaboration with the Director of Statistical Operations, develops goals and objectives on an annual basis, and ensure 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.
* Keep abreast with emerging developments and trends in the field of clinical biostatistics.
* Provide consultation and assistance to the Director of Statistical Operations in identification and development of new services to be offered by the group in order to meet customer needs.

*Financial Management *

* Maintain expected financial projections, report/escalate projects at risk, and work within statistics 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 Statistics 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.

*Statistical Analysis and Contribution to Clinical Research Projects*

* Provides statistical leadership for all assigned team projects.
* Proposes novel statistical methodological approaches leading to improvement in the efficiency and sensitivity of study results. Determines the need for development of novel statistical methodology.
* Develop strategy for data presentation and inference. Ensure appropriate interpretation of statistical deliverables in collaboration with other functions.
* Leads all statistical aspects of a clinical research or analytic project. Collaborates with project leader, principal investigator, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the research project, and to jointly achieve objectives and timelines. Represents the functional group in project team meetings and contributes constructively to project discussions.
* Coordinates resources required to meet needs of own projects, including junior statisticians, statistical programmers, informaticists, and others as needed.
* Serves as statistical resource for other members of the statistical team.
* Mentors others and communicates statistical topics effectively.

*MINIMUM QUALIFICATIONS*

* Position requires a minimum of a Bachelor's degree, nine years of relevant experience to include 4 years in leadership roles.
* A Master's or Doctoral degree in (bio) statistics or related field and at least 9 (preferably 10 or more) years' experience as a statistician in clinical research, and progressively more responsible positions.
* OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

*PREFERRED SKILLS, KNOWLEDGE, AND ABILITIES*

* Excellent interpersonal, communication, 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
* Excellent organizational skills, demonstrated ability to lead in a team environment, and an ability to 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

Duke is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran 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 values.

Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essentialjob functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.