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.
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, and meetings.
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-statisticians.
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 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.
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.
Prior contribution to analysis of research projects, a working knowledge of SAS, and solid command of the English language is required. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
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.