SAS Biostatistician work
Budget: $50 – $0 USD
STAT Part 1: Preparation of the Derived Dataset Specifications
Derived dataset specifications are an extremely important component for generating the results from the study, but these specifications also provide a detailed description of how variables and results are derived from the case report form data. Additionally, the derived data specifications and derived datasets will be needed by the reviewing statistician to understand how the data has been summarized. The variable annotation on the case report forms will map to the derived datasets; the electronic files with the individual case report form data will be referenced in the ADLS dataset, linking all data for a subject, clinician, device, and procedure. Derived datasets will be prepared as SAS7bdat files. The structure of the derived dataset files will follow the FDA guidelines for 1999 compliant datasets.
STAT Part 2: Preparation of the Derived Datasets, Required for Generating the Tables, Figures, and Listings
Specification for the derived datasets will be created and validated to ensure that the calculations and algorithms performed on the CRF-level data are accurate. The derived datasets will be based on Section 7 compliance of the ICH guidelines.
STAT Part 3: Application Programming to Generate the Post-Text Tables
All application programs will be developed, tested, and executed using SAS (version 9.4). Tables and listings will be issued in MS Word format, and data will be available in a variety of common formats; graphics will be prepared in SAS and also available in PowerPoint. The advantage of using these formats is that a minimum amount of modification will be required to craft presentations around the study results. The tables to be generated are outlined in Appendix 1.
Unless otherwise specified, all tables will be produced in landscape mode. Required margins: at least 1.5 inches on top (the binding margin [or left for portrait output]), at least 1 inch on right, left, and bottom.
All fractional numeric values will be printed with a zero to the left of the decimal point (e.g., 0.12, 0.3). Unless otherwise specified, percentage values will be printed with one digit to the right of the decimal point (e.g., 12.8%, 5.4%). Less-than signs “<0.1%” will be printed when values are >0.0 and <0.1% (not 0.0%). Missing data will be represented on subject listings as either a hyphen (“-“) with a corresponding footnote (“ - = unknown or not evaluated”), or as “N/A,” with the footnote “N/A = not applicable,” whichever is appropriate. Dates will be printed in SAS DATE9. format (“DDMONYYYY”, e.g. 01Oct2000). Missing portions of dates will be represented on subject listings as dashes (-- Oct 2000). Dates that are missing because they are not applicable for the subject will be listed as “N/A”, unless otherwise specified.
Derived dataset specifications are an extremely important component for generating the results from the study, but these specifications also provide a detailed description of how variables and results are derived from the case report form data. Additionally, the derived data specifications and derived datasets will be needed by the reviewing statistician to understand how the data has been summarized. The variable annotation on the case report forms will map to the derived datasets; the electronic files with the individual case report form data will be referenced in the ADLS dataset, linking all data for a subject, clinician, device, and procedure. Derived datasets will be prepared as SAS7bdat files. The structure of the derived dataset files will follow the FDA guidelines for 1999 compliant datasets.
STAT Part 2: Preparation of the Derived Datasets, Required for Generating the Tables, Figures, and Listings
Specification for the derived datasets will be created and validated to ensure that the calculations and algorithms performed on the CRF-level data are accurate. The derived datasets will be based on Section 7 compliance of the ICH guidelines.
STAT Part 3: Application Programming to Generate the Post-Text Tables
All application programs will be developed, tested, and executed using SAS (version 9.4). Tables and listings will be issued in MS Word format, and data will be available in a variety of common formats; graphics will be prepared in SAS and also available in PowerPoint. The advantage of using these formats is that a minimum amount of modification will be required to craft presentations around the study results. The tables to be generated are outlined in Appendix 1.
Unless otherwise specified, all tables will be produced in landscape mode. Required margins: at least 1.5 inches on top (the binding margin [or left for portrait output]), at least 1 inch on right, left, and bottom.
All fractional numeric values will be printed with a zero to the left of the decimal point (e.g., 0.12, 0.3). Unless otherwise specified, percentage values will be printed with one digit to the right of the decimal point (e.g., 12.8%, 5.4%). Less-than signs “<0.1%” will be printed when values are >0.0 and <0.1% (not 0.0%). Missing data will be represented on subject listings as either a hyphen (“-“) with a corresponding footnote (“ - = unknown or not evaluated”), or as “N/A,” with the footnote “N/A = not applicable,” whichever is appropriate. Dates will be printed in SAS DATE9. format (“DDMONYYYY”, e.g. 01Oct2000). Missing portions of dates will be represented on subject listings as dashes (-- Oct 2000). Dates that are missing because they are not applicable for the subject will be listed as “N/A”, unless otherwise specified.