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Requisition Number:: 172971
Date: Jan 7, 2022
Durham, NC, US, 27710
Personnel Area: MEDICAL CENTER
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
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.
Performs introductory and intermediate statistical analysis and programming
for assigned clinical trials and laboratory research projects in the Duke
Cancer Institute's DCI Biostatistics Shared Resource BSR. Works
closely with biostatistics faculty and higher level staff to manage project
responsibilities. Participates in all aspects of assigned research projects in
collaboration with the assigned disease teams including data management,
statistical analysis, report generation, study planning, project management,
Data Management, Programming, Statistical Analysis, and Collaboration
You are expected to seek oversight and guidance from your manager, senior
biostatisticians and faculty on all aspects of your assigned projects. They
will regularly give guidance and input in all areas of your work including
managing the statistical aspects, research questions and hypothesis
generation, researching new statistical methods, drafting statistical analysis
plans SAPs, preparing reports, reviewing and revising abstracts and
manuscripts, reviewing data capture techniques, and producing other work
product. Consult and collaborate with faculty, senior biostatisticians, study
personnel, colleagues, DCI Members, and the Principal Investigator PI on
assigned studies and with other study personnel as needed to make project-
related decisions efficiently.
Participate in all aspects of research projects including research question
and hypothesis generation, study design, database development, statistical
analysis and summarization, and publication. Serve as an active member of the
study team to manage statistical aspects of research projects.
Work on all types of research projects including clinical trials and
observational studies. Conduct power and sample size estimates, creates
randomization schemas, and performs other study design activities. Contribute
to the thought process of endpoint selection. Perform introductory to
intermediate statistical planning, programming, and analysis. Research new
statistical methods when needed 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.
Create analysis datasets using SAS or other statistical software. Combine
multiple disparate raw databases and derives analysis variables accurately.
Effectively prioritize multiple competing projects and deadlines. Draft
statistical analysis plans (SAPs), results reports, and other work products.
Use statistical and medical understanding to propose analyses and interpret
results. Present results summaries and interpretations to study team.
Scientific Writing, Editing, and Publication
Critically review and edit abstract and manuscript drafts. Draft statistical
methods sections for manuscripts and integrate statistical results and
interpretations throughout the manuscript with guidance. Write statistical
methods and considerations sections for protocols and critically review and
revise full protocols under guidance. Draft responses to reviewer critiques.
Regulatory, Data Security, and Reproducibility
Remains abreast of current regulatory standards and requirements. Ensures
regulatory requirements are upheld for the statistician, including being
listed as key personnel on protocols and maintaining current regulatory
training (CITI, RCR, etc.). Works in conjunction with the database team to
perform review and approval of data collection tools, data checks, fields, and
formats with supervision from faculty or senior staff. 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. Follows all of DCI and
Duke's data safety and regulatory guidelines. Follow all data security and
regulatory guidelines outlined by governing bodies such as the FDA, NIH, etc.
Attend study team meetings and actively participate in discussion of
endpoints, hypotheses, and goals of study during planning with the study team.
Effectively explains introductory to intermediate statistical concepts to non-
Communicates concerns clearly in a professional manner. Responds timely to
emails, phone calls and questions. Refers complex questions and escalate
issues to others as appropriate. Works effectively and efficiently with other
teams such as Bioinformatics, Information Systems, the Office of Regulatory
Affairs, etc. to support research project needs.
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
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.
The preferred candidate will have experience working with real-world clinical
data, intermediate to advanced programming skills in both SAS and R, and
exceptional verbal and written communication skills. Cancer research
experience is a plus, but not required. Experience handling competing projects
and deadlines is preferred. A strong drive to advance own statistical and
programming knowledge and abilities is desired.
Work requires a minimum of a Master's degree in (bio)statistics or related
field and no relevant experience, or a bachelors degree in (bio) statistics
or related field and 2 years relevant experience, or an equivalent combination
or relevant education and/or work experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE Prior
contribution to analysis of research projects, a working knowledge of SAS, and
solid command of the English language is required.
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
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
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