Statistical Programmer Job Description:
Under the direction of Senior/Principal Statistical Programmer:
Responsible for building programs to create SAS datasets from the clinical database, external data sources, and other sources while following the clinical study's protocol or statistical plans.
Providing statistical programming and validation support for clinical study reports. Overseeing programming activities by external vendors (e.g., CROs) and coordinating programming activities among the study programmers to achieve timely progress in the following areas: SDTM datasets, ADaM datasets, statistical tables, figures, listings, Interim Analysis, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), DSUR, PSUR, IB, progress reports, electronic submissions and other internal and external requests (e.g., publications). Providing input in developing statistical analysis plans, producing specifications of analysis datasets, including the analysis datasets for tumor assessment using RECIST criteria, validation plans, and other related documents
Statistical Programmer Job Qualification:
Statistical Programmer should be able to: Build SAS datasets from clinical database.
Develop SAS macros, templates and utilities for data cleaning and reporting. Utilize CDISC guidelines to build SDTM and ADaM datasets. Implement analyses specified in the protocol or the Statistical Analysis Plan (SAP) while working with the project statistician.
Ensure CRF meets the guidelines of the protocol and check for consistency and adequacy. Write SAS programs to generate tables, listings, and figures and analysis datasets. Review CRF annotations and data specifications.
Work with Biostatistics and Data Management member on various clinical projects. Identify and edit checks per the data validation plan or data management plan. Validate the programmed analysis datasets, tables, listing and figures.
Perform analyses defined in the statistical analysis. Prepare clinical and statistical summary reports. Communicate with programming and statistics leads.
Utilize SAS programming skills within project team and perform all programming required for clinical trial analysis and reporting. Perform quality control on final reports. Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues. Good understanding with different phases of clinical trials, protocols, and CRF designs.
Two to three year's working experience in SAS programming for phase I-IV clinical trials in a pharmaceutical/CRO environment.