Assistant Director Of Applied Biostatistics

Essential Duties

1.Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas. 2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility. 3.

Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives. 4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility. 5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances. 6.

Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies. 7. Directs a staff of exempt and non-exempt employees. 8. May perform other duties as assigned.

Required Education and Experience

Bachelor's Degree in related field and eight years of experience or an equivalent combination of education and related experience.

Background Check Requirements

All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.

Position Focus:

Under the leadership of the Sr. Associate Director of Research Operations, lead a team to support biostatistics and programming activities for YCCI managed research studies.

Provide expertise and leadership in applied biostatistics for multiple clinical studies in all stages of the research lifecycle, including study design and protocol development, study reporting (DSMBs, NIH, FDA, ClinicalTrials.gov, and other stakeholders), and statistical analysis. Supervise, train, mentor, and develop biostatistics and programming team to provide a diverse portfolio of biostatistics services and meet client expectations.

Collaborate with applicable departments including Project Management, Clinical Data Management, and Regulatory Affairs to support database development, study reporting, data sharing, data quality, and statistical analysis. Identify opportunities to build process efficiencies and work collaboratively with teams who have studies in development through full operational deployment and closeout as it relates to biostatistical needs. Perform Human Relations activities related to direct reports.

As the leader of the Applied Biostatistics team, the position ensures an environment that promotes quality research management and facilitates interdisciplinary research activities. The Assistant Director of Applied Biostatistics further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinating initiatives which identify, prevent, and appropriately mitigate clinical trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university's broader compliance strategy and framework. The position coordinates effectively with other units/departments within the university such as Yale Center for Analytical Sciences (YCAS), EHR research team (JDAT), Human Research Protection Program, and Biomedical Informatics & Data Science (BIDS); clinical trials sponsors and vendors; and with research teams at other academic centers as needed.

Familiar with a variety of the field's concepts, practices, and procedures and relies on experience and judgment to plan and accomplish goals. This position may require remote work on either a regular or temporary, part- time or full-time basis.

Preferred Education, Experience and Skills:

Master's degree and experience 10+ yrs supporting Biostatistical needs in clinical trials setting. SQL & SAS programming skills (Base, Macro, ODS). eCTD data submissions, FHIR, data integration from EHR systems (Epic)/other eSource data sources (Direct Data Capture, eCOA/ePRO). Reporting Clinical Trials Data to federal agencies to meet regulatory requirements (CT.gov, NIH, FDA).

Posting Disclaimer

The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.