BIOSTATISTICIAN III-Applied Genomics and Precision Medicine - 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

Manages trial/project responsibilities independen tly. Handles multiplecompeting projects and deadlines, and coordinates all the statisticalneeds of each clinical trial/project. Performs inter mediate and advanced statistical analysis and programming for multi-center phase I-IV clinical trials and/or clinical research projects.


Work Performed

With minimal or no guidance, prepares statistical analysis plans anperforms and interprets basic and complex analyses.Uses statisticaland medical understanding to propose and perform additional analyses appropriately and independently. Learns new statistical m ethods andapplies new skills to future projects.Documents analyses, creates summaries, and presents results in written and verbal form to requestors. Writes statistical text for studyreports and clinical publications . Prepares methods sections andanalysis plans for incorporation in abstracts, manuscripts, grants.Discusses analytic issues related to other findings within a clinicaltrial/project. Understands how clinical trial/projectr esults fit in the context of results from similar clinical trials/ projects in the broader field. Designs analysis data set specifications and providesinput on those prepared by junior statisticians or statistical programmers.Writes own SAS and/or S-plus code, finds errors, corrects, and validates output and results. Performs complex programming efficiently, usecomplicated SAS procedures and options. Programs analysis data setsusing SAS and/or reviews those programmed by others to ensure quality products; combines multiple disparate raw databases and derives analysis variables accurately. Considers alternative programming approaches to improve quality and/or efficiency.Collaborates effectively with statistical programmers that support clinical trial/projects. Identifies potential data problems from analytic queries and takes appropriate initiative to guide the processof resolution. Demonstrates thorough understanding of clinicaltrial/project data collection processes and data sets and share sknowledge with collaborators, fellow statisticians, and programmers.Hel ps less experienced programmers and/or statisticians with programming skills.

 

Participates in all statistical aspects of a trial/project with minimal guidance. Collaborates with project leader, principal investigator,ot her clinical investigators, and external government or industryrepresent atives to affect significant decisions regarding the trial/project, and to jointly achieve objectives and timelines. Represents the functional gro up in project team meetings and contributes constructively to project discussions.Understands the contracted scope of work and forecasts monthly hours expected to complete each trial/project. Proactively identifies potential out-of-scope activity and brings to the attention of projectleade r. Creates timelines for statistical project management withminimal or no assistance.Contributes to the thought process of endpoint selection a nd studydesign. Calculates samples sizes, power calculations, and inter imstopping guidelines, with guidance. Provides review and approval ofda ta collection tools, data correction criteria and procedures,identification of critical data fields, and endpoint collection documents. Understands study data and the intricacies of the process through which it is being collected.Collaborates closely with investigators, sponsors, and other trial leadership to ensure that trial/project results and conclusions are presented accurately and without bias. Leads the statistical team responsible for designing and validating analysis data sets, programs,and statistical output products (tables, listings, figures).Adheres to standard operating procedures 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, or other regulatory agency as they apply to statistics and programming. Demonstrates a solid understanding of the clinical drug and/or device development process. Perform other related duties incidental to the work described herein.The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.

 

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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