School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's 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.

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.

JOB DESCRIPTION

Serve as an expert statistical programming resource within the Department of Population Health Sciences DataShare. The DataShare supports the conduct of clinical research using electronic health records and large administrative and clinical databases. The person in this role must possess an expert understanding of electronic health records, health insurance claims, and clinical registry data, healthcare coding algorithms, data reporting and visualization techniques, as well as expertise and experience with the application of good clinical data management practices. They are an experienced manager with excellent communications skills. They are detail-oriented, collaborative and adept at liaising with IT teams to design, adapt, and maintain systems required to enhance and maintain the technical infrastructure required for clinical research data. Close collaboration with other disciplines and departments within and across Duke and external organizations is necessary.

WORK PERFORMED

Personnel Management

• Supervise, direct, coach, and perform annual performance reviews of direct reports.
• Enable staff development and maintain job designs and descriptions.
• Forecast staffing needs, assign staff, and hire staff, as needed. Provide updates to supervisor.
• Mentor junior staff and educate others in formal, informal, and conference settings.
• Estimate and manage workload and provide status updates to the DataShare Operations Director (i.e. supervisor) and/or customers.
• Estimate time required to complete various tasks and provide status updates to supervisor and/or customers.
• Promote a collaborative and professional work culture.
• Participate in professional development activities to continuously enhance personnel management skills.

Operational and Strategic Management

• Develop, implement, and monitor optimal standardized workflows.
• Liaise with other groups across the University and with information technology (IT) groups to maximize efficiency.
• Collaborate with information technology groups to implement network, database, and hardware/software requirements for maintaining research data and regulatory approval.
• Keep current on industry advances – SAS, R, Python, informatics, etc.
• Monitor and take initiative to recommend improvements to the technical infrastructure for clinical research data. Liaise with IT groups to design and initiate
• Attend and participate in meetings with DataShare Leadership to support overall operation of the DataShare.

Business Development and Financial Management

• Assist with project budgets and represent team in budget and proposal discussions.
• Provide input in annual DataShare shared resource budgeting process.

Regulatory and Quality Management

• Oversee and implement the development and maintenance of SOPs, work instructions, documentation, and programming tools that support the technical infrastructure required to maintain and efficiently use research databases.
• Serve as the data steward for DataShare research databases (e.g. electronic health records and large administrative claims and clinical data).
• Participate and/or represent DataShare in internal, sponsor, and regulatory audits of the DataShare technical infrastructure.
• Work with direct reports and DataShare Governance Team to monitor regulatory workflows.

Technical Leadership

• Learn, apply, and share new techniques to increase efficiencies.
• Implement departmental infrastructure improvements and industry trend solutions (regulatory, technical, etc.).
• Oversee the development of software tools to support the DPHS DataShare research infrastructure and ongoing research studies.
• Serve as statistical programming expert for DataShare and direct reports.
• Lead or assist on production or research projects to keep skills current. This may include extracting electronic health records, loading and processing data, and developing, coding, and documenting SQL and SAS programs.
• Educate others within and outside the DataShare on statistical programming.
• Provide expert-level programming support on research projects, including design, technical specification development, data collection, analysis, presentation, and reporting.

Other Duties:

• Performs other related duties incidental to the work described herein.

Minimum Qualifications

Education

Work requires a Bachelors degree in mathematics or computer related field, or equivalent coursework or technical training.

Experience

Work requires eight years of clinical trials statistical programming experience along with expert knowledge of SAS software. Some experience or training in employee supervision is required for staff management functions. Preferred experience includes knowledge of several computer languages and good knowledge of the UNIX operating system.OR ANY OTHER EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

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.