Director, Statistical Operations, DCRI Statistics - Military Veterans

at Duke University and Duke University Health System

Durham, North Carolina

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 the day-to-day operational leadership of the DCRI Statistics group and serve as the primary contact and point person for DCRI statistical operations.  Work in partnership with the DCRI Statistics Therapeutic Area Faculty Director to develop and implement strategies that enhance the performance and capabilities of DCRI’s statistical services and ensure the alignment of goals and objectives with the mission, vision, and goals of the DCRI.            

 

Work Performed

 

Personnel Management

 

Oversee supervision of DCRI Statistics personnel including, but not limited to, recruitment, hiring, retention, promotions, scheduling and work assignments, coaching, corrective action, and career development.  Directly supervise Associate Directors in the DCRI Statistics group.

 

In collaboration with DCRI Statistics leadership (includes Associate Directors and Faculty Leaders), develop and implement strategies and programs to optimize employee satisfaction and morale including, but not limited to, employee reward and recognition programs, and orientation programs for new employees. 

 

In collaboration with DCRI Statistics leadership, develop career paths and provide ongoing mentoring, training, and education to all staff. 

 

Ensure that all staff have clearly defined job descriptions, responsibilities, and performance standards and expectations.  Oversee all components of performance plans, coaching and feedback, ongoing evaluation of performance, and areas of development. 

 

Conduct regular staff meetings and ensure that staff are kept abreast of departmental and organizational activities, goals, policies, procedures, and priorities. 

 

Develop/oversee forecasts regarding workload volume and make recommendations regarding staffing requirements to fulfill project deliverables while ensuring optimal efficiency and quality.

 

Utilize available tools to manage resourcing and upcoming resource needs.

 

Be an advocate for staff – providing a space for listening, learning, and acknowledgement.

 

Work closely with new statistical faculty and staff to ensure clarity of responsibilities.

 

Operations Management

Serve as an internal expert resource regarding statistical operations. 

 

Serve as a liaison with the statistical faculty of the DCRI.

 

Ensure that the activities of the non-faculty statisticians and statistical programmers are appropriately coordinated and prioritized. 

 

Provide primary operational oversight of any studies where no other DCRI service is contracted or no project leader at the DCRI is assigned to the study.  Where needed work with the respective DCRI functional group leader if project leader support is required.

 

Oversee the development and implementation of workflow and operational processes to maximize standardization of approaches across projects and achieve optimal efficiency.  Identify and approve situations in which deviations from established processes are appropriate.  

 

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.  Oversee the implementation of new technologies as well as upgrades to existing systems as well as any training needs. 

 

Ensure that appropriate operational plans are developed for the statistical component of all projects, as required, including workflow, project-specific work instructions, documentation, quality control, roles and responsibilities, and timelines. 

 

Oversee the monitoring of progress and performance of statistical services for all projects in which DCRI Statistics has a role; to include prioritization, data integrity, timeliness of deliverables, compliance, and adherence to scope and budget.  Ensure that delays are identified, communicated as needed, and that appropriate interventions are implemented to mitigate impact.  Ensure that issues regarding statistical services are raised and addressed appropriately at project review meetings and escalated to DCRI Senior Leaders when necessary.

 

Identify operational issues, obstacles, and barriers across projects.  Analyze patterns and trends, prioritize opportunities for improvement, and facilitate efforts to implement enhancements to processes and systems.   Oversee quality improvement initiatives within statistics and provide leadership for cross-functional and organization-wide initiatives.

 

Establish appropriate measures of workload volume, productivity, utilization, and service quality.  Work with the DCRI CFO and Head of Research Operations to establish appropriate targets.  Monitor performance on an ongoing basis and implement appropriate interventions to ensure achievement of targets.

 

 

Regulatory Compliance

Ensure that SOPs are in place and followed for all statistical activities that are subject to regulatory requirements and ensure consistency with SOPs of other functional groups.  Provide ongoing oversight of procedures and look for areas of efficiency – updating SOPs where required and/or adjusting training requirements for staff. 

 

Represent DCRI statistical operations in all audits including internal compliance audits, sponsor audits, and audits conducted by regulatory authorities.  Review audit reports, provide input for audit responses prepared by Quality Assurance and develop corrective action plans.  Ensure that corrective action plans are fully implemented within the agreed upon timelines.

 

Business Development

Oversee the development of proposals, budgets, and deliverables.

 

Represent DCRI statistical operations in collaboration with statistics faculty in business development activities including at sponsor meetings, capability presentations, and bid-defense meetings.  Provide input into capability materials (slide presentations, brochures, etc.) regarding statistical services and serve as primary contact for the Faculty Resource Center and functional group leaders related to potential new work. 

 

Lead the development of bids and proposals for statistical services.  Ensure that proposed services reflect the needs of the sponsor and that budgets are competitive. 

 

Financial Management

Provide input in the development and use of cost standards for statistical services in the DCRI pricing model.  Review and revise cost standards as needed and provide input regarding pricing rates for statistical staff. 

 

Oversee development of project budgets in collaboration with Associate Directors and Statistical Faculty leaders and assure they align with the scope-of-work.  Maintain expected financial projections, report/escalate projects at risk, and work within statistics and across functional groups to make changes where necessary.

 

Prepare budgetary forecasts for functional group expenses (operating and capital) on an annual basis and for the statistical component of all DCRI statistical projects in collaboration with Statistics Leadership. Ensure appropriate utilization of resources and adherence to targets.  Monitor expenditure of funds relative to budget, provide appropriate justifications for variances, and ensure that appropriate interventions are implemented when required. 

 

Manage DCRI statistics work/budgets for effort that takes place outside of DCRI (i.e., within the broader Duke system) to assure effort is covered while also prioritizing projects on an ongoing basis. 

 

Utilize DCRI tools to oversee financial aspects of projects and work with the respective teams to understand any concerns or areas that need attention. 

 

Strategic Development

Develop goals and objectives for DCRI statistical operations on an annual basis and communicate to all DCRI Statistics staff.  Ensure alignment of functional group objectives with the mission, vision, and goals of the DCRI.  Participate in DCRI wide strategic planning discussions. 

 

In conjunction with statistics faculty and operational leaders define and adjust key areas of work for DCRI Statistics – this may include regulated vs non-regulated trials, data-safety-monitoring-committees, observational studies, registries, claims, manuscripts, etc.

 

Keep abreast with emerging developments and trends in the field of statistics through participation in professional organizations and review of applicable literature. 

 

Develop and maintain a strategic plan for the future direction of DCRI statistical operations to ensure the DCRI’s continued position as a leading ARO.  In collaboration with statistical faculty and staff develop innovative statistical services that meet customer needs and are relevant to potential customers.  This would include any required training/workforce development.

 

Preferred Skills, Knowledge & Abilities

Understanding of statistical elements of clinical research is important to this role and direct statistical or statistical programming experience is preferred, however it is not required.

 

Previous personnel management and supervisory experience.

 

Leadership skills including proven ability to functional effectively in a matrix organization.

 

Strong knowledge of information technology.

 

Excellent organizational, planning, prioritization, facilitation, negotiation, and decision-making skills.

 

Excellent analytical and problem-solving skills.

 

Excellent oral and written communication skills, including public speaking.

 

Knowledge of continuous quality improvement theory and methodology.  

 

Previous financial management experience.

 

Knowledge of FDA/international regulatory requirements and/or observational/ clinical registry requirements. 

 

Knowledge of CDISC.

 

Knowledge of R, SAS, Stata, and/or Python

 

REPORTING RELATIONSHIP

Reports to the Head of Research Operations of the DCRI. 

 

Minimum Qualifications

 

 

Education

Work requires a Bachelor's degree in Biology, Physiology, Public Health, related scientific field, or other health related field. 

Bachelor’s degree in statistics, quantitative science, or relevant health/science related field preferred.  Advance degree(s) strongly preferred but not required.

 

 

Experience

 

Work requires seven years experience managing clinical research studies. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE  At least five years of experience in a management or institutional leadership role overseeing a clinical research group and demonstrated success in academia or the pharmaceutical, medical device, or biotechnology industries preferred. 

 

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.

 

Durham, North Carolina

As a world-class academic and health care system, Duke Health strives to transform medicine and health locally and globally through innovative scientific research, rapid translation of breakthrough discoveries, educating future clinical and scientific leaders, advocating and practicing evidence-based medicine to improve community health, and leading efforts to eliminate health inequalities.

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