Work with the DCI Biostatistics Shared Resource as a biostatistician across multiple projects across disease-specific groups as assigned. 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
Develops and analyzes a variety of research data using sophisticated statistical methods. Keep abreast of the advanced statistical modeling and computing tools.
Serve as a resource for other statisticians about a broad spectrum of analysis methods. Designs analysis data set specifications and provides input on those prepared by junior statisticians or statistical programmers. 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. Considers alternative programming approaches to improve quality and/or efficiency
Collaborates effectively with statistical programmers that support clinical trial/projects. Identifies potential data problems from analytic queries and takes appropriate initiative to guide the process of resolution. Demonstrates thorough understanding of clinical trial/project data collection processes and data sets and shares knowledge with collaborators, fellow statisticians, and programmers.
Guide all statistical aspects of a trial/project without guidance. 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.
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. Creates timelines for statistical project management without assistance.
Contribute to the thought process of endpoint selection and study design. Calculate samples sizes, power calculations, and interim stopping guidelines without guidance or minimal guidance. Draft statistical sections for study synopses and protocols, without guidance or minimal guidance.
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).
Consistently handles multiple competing projects and deadlines. Present information on topics relevant to statistics and statistical operations at internal statistics meetings. Give oral presentations of key statistical methods, operational issues, study results, or project status at trial or clinical project meetings.
Scientific Writing, Editing, and Publication
Prepare statistical method sections for inclusion in study protocols. Review the design and content of database designs and data edit checks. Develops and validates SAS and other programs to support statistical analyses. Provides interpretations of statistical results, and prepares the relevant statistical sections for study reports. Creates and maintains biostatistical documentation, including descriptions of methods, programs and results. Prepares electronic files using appropriate formats for submission to regulatory agencies. Participates in the development of standardization procedures for statistical functions. Reviews and audits statistical analysis plans, SAS programs, and statistical reports including tables, listings, and figures. Provide guidance to more junior biostatisticians.
Write 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.
With minimal or no guidance, prepares statistical analysis plans. Performs and interprets basic and complex analyses without guidance. Uses statistical and medical understanding to propose and perform additional analyses appropriately and independently.
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.
Discusses analytic issues related to other findings within a clinical trial/project. Independently and proactively 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
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. Collaborate closely with investigators, sponsors, and other trial leadership to ensure that trial/project results and conclusions are presented accurately and without bias.
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.
Duke Entity MEDICAL CENTER
Job Family Level 74
Full Time / Part Time FULL TIME
Regular / Temporary Regular
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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.
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.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR 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.
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.
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