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.

 

Biostatistics Shared Resource

 

Position Description

 

Occupational Summary

Perform intermediate and advanced statistical analysis and programming for assigned research projects in the Duke Cancer Institute’s [DCI] Biostatistics Shared Resource.  Participate in all aspects of research projects.  Manage projects and responsibilities independently, handle multiple competing projects and deadlines, and coordinate all statistical needs.  Serve as the expert resource for staff and faculty across DCI and within the Biostatistics Shared Resource, in particular, for lower level biostatisticians.

 

Work Preformed

Research Design, Programming, and Collaboration 

Participate in all aspects of research projects including research question and hypothesis generation, study design, database development, statistical analysis and summarization, and publication.  Act as the lead statistician and manage the statistical aspects with decreasing oversight from faculty or senior staff statisticians.  Attend study team meetings.  Work with DCI Members on all types of research projects including clinical trials and observational studies.  Demonstrate knowledge of intermediate to advanced statistical concepts and effectively explain these concepts to non-statisticians.  Conduct power and sample size estimates, create randomization schemas, and performs other study design activities with guidance from faculty or senior statisticians.  Contribute to the thought process of endpoint selection.  Perform intermediate to advanced statistical planning, programming, and analysis with some guidance.  Research new statistical methods and apply new skills to future projects.  Write statistical code using statistical software (SAS, R, Stata, MPlus, etc.), troubleshoot run and convergence issues, and validate output and results independently.  Create analysis datasets using SAS or other statistical software.  Combine multiple disparate raw databases and derive analysis variables accurately.  Consider alternative programming approaches to improve quality and efficiency.  Support faculty and senior staff statisticians in handling multiple competing projects and deadlines.  Draft statistical analysis plans (SAPs), results reports, and other work products with minimal guidance.  Use statistical and medical understanding to appropriately propose analyses and interpret results.  Present result summaries and interpretations to study team.

 

Scientific Writing, Editing, and Publication

Critically review and edit abstracts and manuscript drafts.  Draft statistical methods sections for manuscripts and integrate statistical results and interpretations throughout the manuscript.  Write statistical methods and considerations sections for protocols; critically review and revise full protocols.  Work with the Principal Investigators [PIs] on grant writing and development, including study planning.  Write statistical methods sections for grants with some guidance.  Draft responses to reviewer critiques independently.

 

Regulatory, Data Security, and Reproducibility 

Remain abreast of current regulatory standards and requirements.  Ensure regulatory requirements are upheld for the statistician, including being listed as key personnel on protocols and maintaining current regulatory training (CITI, RCR, etc.).  Work in conjunction with the database team to perform review and approval of data collection tools, data checks, fields, and formats with minimal supervision.  Advise study team on appropriate data capture to meet study objectives. Follow programming good practices and utilize tools to ensure reproducibility and replicability such as GitLab/GitHub, SAS ODS output, R Markdown, etc.  Follow all of DCI and Duke’s data safety and regulatory guidelines.  Follows all data security and regulatory guidelines outlined by governing bodies such as the FDA, NIH, etc.

 

Communication 

Serves as primary liaison with study personnel, colleagues, and PI for assigned studies.  Collaborate and communicate with other study personnel as needed.  Communicate concerns clearly in a professional manner.  Respond timely to emails, phone calls and questions.  Refer complex questions and escalate issues to others as appropriate.  Work effectively and efficiently with other teams such as Bioinformatics, Information Systems, the Office of Regulatory Affairs, etc. to support project needs.  Communicate and collaborate with the study team to make project-related decisions efficiently.  Actively participate in discussion of endpoints, hypotheses, and goals of study during planning with the study team.

 

Leadership 

Be an expert resource for staff and faculty within the Biostatistics Shared Resource and across DCI.  Be a resource for lower level biostatisticians on aspects of research studies, programming, and intermediate to advanced statistical analysis.  Review analysis datasets and derived variables programmed by junior statisticians to ensure quality product.  Present to the DCI Biostatistics Shared Resource staff and/or faculty on expert subject areas.

 

Ethics

Know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern statistics and research.  Maintain Duke and project specific training and certification requirements.

And other work as assigned. 

 

The above statements describe the general nature and level of work being performed. This is not intended to be an exhaustive list of all responsibilities and duties required.  Employees may be directed to perform job-related tasks other than those specifically presented in this description.

The intent of this job description is to be representative of the level and the types of duties and responsibilities that will be required of this position and shall not be construed as a declaration of the total specific duties and responsibilities. 

 

Preferences

The preferred candidate will have experience working with clinical trials and observational studies across a variety of disease areas, extensive programming skills with both SAS and R, and exceptional verbal and written communication skills. Cancer research experience is a plus, but not required. Experience handling multiple projects and competing deadlines is preferred. A strong drive to advance own statistical and programming knowledge and abilities is desired.

 

Qualifications Required At This Level

 

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 ofclinical 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. Desirableexperience 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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