Protocol input, randomization schedule, and database activities.
Works with project team to decide on appropriate study design and statistical methodology for routine designs.
Responsible for protocol review.
Development of randomization schedule, sample size and power calculations.
Responsible for assuring that data for statistical analyses are accurate.
Implementation of protocol methodology and statistical analysis plans.
Responsible for the accuracy and timeliness of statistical input into reports or decisions.
Development of alternative analysis strategies when changes to planned analyses are needed.
Responsible for computer programs that are accurate, efficient and well documented.
Demonstrates understanding of statistical concepts and methodologies.
Development of the Statistical Methods section.
Responsible for accuracy of statistical tables and data listings, and accuracy of report text.
Identifies and corrects flaws in interpretation of results, inconsistency in presentation or inference.
Ensures accuracy of report text and consistency between summary tables in the body of reports and the corresponding statistical tables and listings.
Works collaboratively with peers to develop quality protocols, CRF, schema, and reports per agreed timelines.
Provides accurate and timely answers to routine questions from upper management.
Communicates an understanding of basic clinical principles for his/her project and acts in accordance with those principles.
Clearly communicate basic statistical concepts to other scientists and nonscientists. Informs supervisor or manager on important issues in a timely manner.
Effectively mentors non-statistical peers with regard to basic statistical methodology and departmental operations.