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

Manages trial/project responsibilities independently. Handles multiple competing projects and deadlines, and coordinates all the statistical needs of each clinical trial/project. Performs intermediate and advanced statistical analysis and programming for clinical research projects with particular emphasis on analyses based on clinical trial data, electronic health record data and other novel data sources.

 

Work Performed

Collaborates with clinical investigators to translate clinical goals into questions that can be answered using available data and statistical techniques. With minimal or no guidance, prepares statistical analysis plans for abstracts or manuscripts targeted to a clinical audience while incorporating input from statistician mentors and from clinical collaborators.

Performs statistical analyses laid out in the analysis plan. Uses statistical and medical understanding to propose and perform additional analyses appropriately and independently. Learns new statistical methods as needed, and applies new skills to future projects.

Documents analyses, creates summaries, and presents results in written and verbal form to requestors. Writes statistical text for study reports and clinical publications. Able to work on any phase of a manuscript project, from initial meeting with an investigator to final review of a manuscript prior to submission for publication (checking presentation of results for accuracy and appropriate interpretation) and responding to reviewer comments. Contributes meaningfully to discussions of analyses with clinical investigators and other statisticians and identifies next steps for analyses.

Discusses analytic issues related to other findings within a clinical trial/project. Understands how clinical trial/project results fit in the context of results from similar clinical trials/projects in the broader field.

Leads or participates actively in the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products. Collaborates effectively with statistical programmers, informaticists and data managers who support their projects. Identifies potential data problems from analytic queries and takes appropriate initiative to guide the process of resolution. Demonstrates understanding of project data collection processes and data sets and shares knowledge with collaborators.

Contributes to the thought process of endpoint selection and study design. Calculates samples sizes and power calculations with guidance. Drafts statistical sections for study synopses and protocols, with guidance.

Proficient in SAS and/or R; finds errors, corrects, and validates output and results. Performs complex programming efficiently, uses complicated SAS and/or R procedures and options. Programs analysis datasets using SAS and/or R and/or reviews those programmed by others to ensure quality products; combines multiple disparate raw databases and derives analysis variables accurately. Uses complicated SAS and/or R procedures and options and programs with increasing efficiency. Considers alternative programming approaches to improve quality and/or efficiency. Helps less experienced programmers and/or statisticians with programming skills.

Handles and secures highly confidential and sensitive analyses and documentation. Learns IT tools and analytical methods appropriate for projects.  Collaborates closely with clinical investigators, other statisticians and statistical programmers to share and document this knowledge.

Participates in all statistical aspects of a project, with minimal guidance. Collaborates with project leader, principal investigator, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the project, and to jointly achieve objectives and timelines. Represents the functional group in project team meetings and contributes constructively to project discussions. Understands the contracted scope of work and estimates hours and resources expected to complete each project. Proactively identifies potential out-of-scope activity and brings to the attention of project leader. Creates timelines for statistical project management with minimal or no assistance.

Adheres to standard operating procedures (SOPs) of the functional department as they apply to documentation and validation of clinical research statistics. Understands and remains abreast of guidelines from the FDA, ICH, EMEA, IRB, HIPAA or other regulatory agency as they apply to statistics and programming. Demonstrates a solid understanding of the clinical drug and/or device development process.

Collaborates effectively with a variety of types of individuals: programmers, statisticians (both junior and senior), medical personnel, and representatives within the business community. Develops leadership and communication skills and shares them with others.

Learns about clinical aspects of the research, as appropriate.

Performs other related duties incidental to the work described herein.


Skills
SAS or R, clinical statistics,excellent written and verbal communication skills

 

 

Minimum Qualifications

 

 

 

 

Education

 

Position requires a minimum of a Doctoral degree in (bio) statistics or related field and no relevant experience, or a Master's degree in (bio) statistics or related field and 2 years relevant experience, or a Bachelor's degree in (bio) statistics or related field and 4 years relevant experience.

 

 

Experience

 

OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE Contribution to analysis of clinical trials and/or clinical research projects, and/or participation in preparation of academic manuscripts or other written summaries of analysis results, thorough experience with SAS, and solid command of the English language is required. Desirable experience includes prior role as a lead statistician on clinical trials and/or clinical research projects that have delivered the agreed-upon end products on time, and prior guidance of lower level or less experienced staff.

 

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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