Biostatistician II

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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Occupational Summary

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.

Work Performed

Data Management, Programming, Statistical Analysis, and Collaboration

• 55%

The Biostatistician II is expected to seek oversight and guidance from their manager, senior biostatisticians and faculty on all aspects of assigned projects.

They will regularly give guidance and input in all areas of work including managing the statistical aspects, research question 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 products. The Biostatistician II will 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.

The Biostatistician II will participate in all aspects of research projects including research question and hypothesis generation, study design, database development, statistical analysis and summarization, and publication. They will serve as an active member of the study team to manage statistical aspects of research projects.

The Biostatistician II will work on all types of research projects including clinical trials and observational studies. They will conduct power and sample size estimates, creates randomization schemas, and performs other study design activities.

They will contribute to the thought process of endpoint selection. The Biostatistician II will perform introductory to intermediate statistical planning, programming, and analysis. They will research new statistical methods when needed and apply new skills to future projects.

They will write statistical code using statistical software (SAS, R, Stata, MPlus, etc.), troubleshoot run and convergence issues, and validate output and results. The Biostatistician II will create analysis datasets using SAS or other statistical software, combine multiple disparate raw databases, and derive analysis variables accurately. They will effectively prioritize multiple competing projects and deadlines.

The Biostatistician II will draft statistical analysis plans (SAPs), results reports, and other work products. They will use statistical and medical understanding to propose analyses and interpret results and will present results summaries and interpretations to the study team.

Scientific Writing, Editing, and Publication

• 15%

The Biostatistician II will critically review and edit abstract and manuscript drafts. They will draft statistical methods sections for manuscripts and integrate statistical results and interpretations throughout the manuscript with guidance. They will write statistical methods and considerations sections for protocols, critically review and revise full protocols, and draft responses to reviewer critiques, with appropriate guidance.

Regulatory, Data Security, and Reproducibility

• 10%

The Biostatistician II will remain abreast of current regulatory standards and requirements. They will ensure regulatory requirements are upheld, including being listed as key personnel on protocols and maintaining current regulatory training (CITI, RCR, etc.). They will work 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.

The Biostatistician II will advise the study team on appropriate data capture to meet study objectives. They will follow programming good practices and utilize tools to ensure reproducibility and replicability such as GitLab/GitHub, SAS ODS output, R Markdown, etc. They will follow all DCI and Duke data safety and regulatory guidelines, as well as all data security and regulatory guidelines outlined by governing bodies such as the FDA, NIH, etc.

Communication

• 15%

The Biostatistician II will attend study team meetings and actively participate in discussion of endpoints, hypotheses, and goals of study during planning with the study team.

They will effectively explain introductory to intermediate statistical concepts to non-statisticians.

The Biostatistician II will communicate concerns clearly and in a professional manner. They will provide timely response to emails, phone calls and questions, and refer complex questions and escalate issues to others as appropriate. They will work effectively and efficiently with other teams such as Bioinformatics, Information Systems, the Office of Regulatory Affairs, etc. to support research project needs.

Ethics

• 5%

The Biostatistician will know and follow policies, standard operating procedures [SOPs], regulations and protocol requirements that govern statistics and research. They will maintain Duke and project-specific training and certification requirements.

And they will complete 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.

Minimum Qualifications

Education

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.

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.

Preferences

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.

Job Code: 00002681 BIOSTATISTICIAN II

Job Level: 74

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