BIOSTATISTICIAN III - Duke Cancer Institute
Duke University

Job Info

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School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation’s top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

Performs intermediate and advanced statistical analysis and programming for assigned clinical and laboratory research projects in the Duke Cancer Institute's [DCI] Biostatistics Shared Resource. Participates in all aspects of research projects. Manages projects and responsibilities independently, handles multiple competing projects and deadlines, and coordinates all statistical needs. Serves as an 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

Participates in all aspects of research projects including research question and hypothesis generation, study design, database development, statistical analysis and summarization, and publication. Acts as the lead statistician and manages the statistical aspects of research projects with decreasing oversight from faculty or senior staff statisticians. Attends study team meetings with or without faculty or senior staff statisticians. Works with DCI Members on all types of research projects including clinical trials and observational studies. Demonstrates knowledge of intermediate to advanced statistical concepts and is able to effectively explain these concepts to non-statisticians. Conducts power and sample size estimates, creates randomization schemas, and performs other study design activities with guidance from faculty or senior statisticians. Contributes to the thought process of endpoint selection. Performs intermediate to advanced statistical planning, programming, and analysis with some guidance from faculty or senior staff statisticians. Researches new statistical methods when needed and applies new skills to future projects. Writes own statistical code using statistical software [SAS, R, Stata, MPlus, etc.], troubleshoots run and convergence issues, and validates output and results independently. Creates analysis datasets using SAS or other statistical software. Combines multiple disparate raw databases and derives analysis variables accurately. Considers alternative programming approaches to improve quality and efficiency. Supports faculty and senior staff statisticians in handling multiple competing projects and deadlines. Drafts statistical analysis plans [SAPs], results reports, and other work products with minimal guidance. Uses statistical and medical understanding to appropriately propose analyses and interpret results. Presents results summaries and interpretations to study team.

Scientific Writing, Editing, and Publication

Critically reviews and edits abstract and manuscript drafts. Drafts statistical methods sections for manuscripts and integrates statistical results and interpretations throughout the manuscript. Writes statistical methods and considerations sections for protocols and critically reviews and revises full protocols. Works with PIs on grant writing and development, including study planning. Writes statistical methods sections for grants with some guidance from faculty or senior staff statisticians. Drafts responses to reviewer critiques independently.

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 minimal supervision. Advises study team on appropriate data capture to meet study objectives. Follows programming good practices and utilizes 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. 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. Collaborates and communicates with other study personnel as needed. 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. Communicates and collaborates with the study team to make project-related decisions efficiently. Actively participates in discussion of endpoints, hypotheses, and goals of study during planning with the study team.

Leadership

Serves as an expert resource for staff and faculty within the Biostatistics Shared Resource and across DCI. Serves as a resource for lower level biostatisticians on aspects of research studies, programming, and intermediate to advanced statistical analysis. Reviews analysis datasets and derived variables programmed by junior statisticians to ensure quality products. Presents 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.

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

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.

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.

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