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 70%
Develops and analyzes a variety of research data using sophisticated statistical methods. Keep 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.
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. Considers alternative programming approaches to improve quality and/or efficiency
Identifies potential data problems from analytic queries and takes appropriate initiative to guide the process of resolution. Possesses broad programming abilities and shares them with others, and maintains programming skills even when delegating many programming tasks to others.
Guide all statistical aspects of a project without guidance. Collaborate with project leader, principal investigator, other clinical investigators, and external government or industry representatives to affect significant decisions regarding the 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. Creates timelines for statistical project management without assistance.
Contribute to the thought process of endpoint selection and study design. Calculate power and samples sizes, and interim stopping guidelines with minimal or no 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: 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.
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 20%
Prepare statistical method sections for inclusion in study protocols. Review the design and content of database designs and data edit checks. Develops and validates 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. Evaluate new statistical methods for data analysis. Assist in setting priorities of work to be done. Participate in training of less senior biostatisticians and other team members. May provide input into the evaluation of team members. Review and help prepare statistical and database management sections of NIH grant applications and other externally supported proposals prior to submission.
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.
Documents analyses, creates summaries, and presents results in written and verbal form. 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 project. Independently and proactively assesses how project results fit in the context of results from similar 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%
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. Collaborate closely with investigators, sponsors, and other trial leadership to ensure that 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 regulatory agencies 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.
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.
2682 BIOSTATISTICIAN III
Job Family Level
Full Time / Part Time
Regular / Temporary
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.
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.
Auto req ID
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.