Works with the Biostatistics Shared Resource and the Alliance for Clinical Trials in Oncology (Alliance) Statistics and Data Center (SDC) with Duke Cancer Institute (DCI) as a biostatistician across multiple projects across disease-specific groups as assigned. This may include collaboration with the Veterans Affairs Cooperative Studies Program in Epidemiology Center-Durham. Manages trial/project responsibilities independently. Handles multiple competing projects and deadlines, and coordinates all the statistical needs of each clinical trial/project. Performs intermediate and advanced statistical analysis and programming for clinical research projects.
Research Design, Programming, and Collaboration 70% Effort
Develops and analyzes a variety of research data using sophisticated statistical methods. Keeps abreast of the advanced statistical modeling and computing tools. May participate in the development and/or selection of appropriate statistical methods and tests, particularly by reviewing simulation studies, coding novel methods, using advanced packages in R, etc.
Writes own SAS and/or R code, finds errors, corrects, and validates output and results. Perform complex programming efficiently, uses complicated SAS procedures and options. Programs analysis datasets using SAS and/or reviews those programmed by others to ensure quality products; combines multiple disparate raw databases and derives analysis variables accurately.
Collaborates with statistical programmers to support clinical trial/projects. Demonstrates thorough understanding of clinical trial/project data collection processes and data sets. Possesses broad programming abilities and shares them with others by consultation and example and maintains programming skills even when delegating many programming tasks to others.
Guide all statistical aspects of a trial/project independently. Collaborate with project leader, principal investigator, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the trial/project, and to jointly achieve objectives and timelines. Represent the functional group in project team meetings and contributes constructively to project discussions.
Understands the contracted scope of work and forecasts monthly hours expected to complete each trial/project. Proactively identifies potential out-of-scope activity, brings to the attention of project leader, and follows up as needed to ensure that it is addressed in a timely manner.
Collaborates effectively and confidently with a variety of types of individuals: programmers, statisticians (both junior and senior), medical personnel, senior scientists and representatives within the business community. Consistently demonstrates leadership qualities in a variety of settings and through multiple experiences and ability to manage project responsibilities independently across a variety of different projects. Lead the statistical team responsible for designing and validating analysis data sets, programs, and statistical output products (tables, listings, figures).
Scientific Writing, Editing, and Publication 20% Effort
Writes statistical methods section of manuscripts for publication. Drafts and/or revises quantitative, epidemiologic, and medical sections of manuscripts. Helps estimate budgets for biostatistical support for larger, more involved clinical studies (NIH program project grants, multicenter clinical trials etc.). Monitors data collection, institutes procedures to assure data quality and guarantees study protocols are followed appropriately. Performs related responsibilities as assigned.
Documents analyses, creates summaries, and presents results in written and verbal form to requestors. Write statistical text for study reports and clinical publications. Prepare methods sections and analysis plans for incorporation in abstracts, manuscripts, grants. Demonstrate ability to work on any phase of a manuscript project, from initial meeting with an investigator to final review of a manuscript prior to submission for publication, without guidance.
Assesses how clinical trial/project results fit in the context of results from similar clinical trials/projects in the broader field. Contributes meaningfully and creatively to discussions of analyses and proactively identifies next steps for analyses.
Regulatory, Data Security, and Reproducibility 10% Effort
Handles and secures highly confidential and sensitive analyses and documentation. Supports the preparation of Data and Safety Monitoring Board reports and final statistical and study reports, including those intended for regulatory submission, and collaborates with medical writers as needed.
Adhere to standard operating procedures of the functional department as they apply to documentation and validation of clinical research statistics. Understands and proactively remains abreast of guidelines from the FDA, ICH, EMEA, IRB, HIPAA, or other regulatory agency as they apply to statistics, programming, and handling of clinical data; monitors compliance to required standards of own work and that of any individuals being mentored. Demonstrates solid understanding of the clinical drug and/or device development process
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.
Experience with R and SAS. Demonstrated ability to plan and carry out studies in clinical research with faculty input as needed. Strong technical writing skills and multiple and varied prior trial/project experiences desirable.
2682 BIOSTATISTICIAN III
Job Family Level
Full Time / Part Time
Regular / Temporary
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Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.
Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
Position requires a minimum of a Doctoral degree in (bio) statistics orrelated field and no relevant experience, or a Master's degree in (bio)statistics or related field and 2 years relevant experience, or aBachelor's degree in (bio) statistics or related field and 4 yearsrelevant experience.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCEContribution to analysis of clinical trials and/or clinical researchprojects, and/or participation in preparation of academic manuscripts orother written summaries of analysis results, thorough experience withSAS, and solid command of the English language is required. Desirableexperience includes prior role as a lead statistician on clinical trialsand/or clinical research projects that have delivered the agreed-uponend products on time, and prior guidance of lower level or lessexperienced staff.
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Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job 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.