Description
Job Responsibilities:- Independently write programs for the creation of analysis datasets, pooled datasets, listings, tables and figures for clinical trials;
- Define data set structure and data specification to build integrated analysis data set for multiple clinical studies;
- Create and transfer data set or report files for internal or external use;
- Review tables and listings, edit check outputs and SAS programs to ensure quality of deliverables;
- Provide input and review to statistical analysis plans, CRFs, and dataset structures;
- Support quality control and quality audit of deliverables
- Programmatically validate programs and outputs generated by contracted CROs;
- Contribute ideas and thoughts towards the optimization of standard operating procedures.
Requirements:
- At least 5 years' experience using SAS in the pharmaceutical or biotech industry;
- Working experience related to Oncology therapeutic and CDISC implementation;
- Bachelor's or Master's degree in Statistics, Biostatistics, Computer Science or equivalent work experience;
- Expertise in SAS/BASE, SAS/STAT, SAS/MACRO;
- Competence with SAS/GRAPH, SQL ;
- Understanding of regulatory requirements and considerations (e.g. GCP, ICH, 21CFR part11, CDISC);
- Excellent organizational, technical, and interpersonal skills;
- Ability to work independently and act with initiative to address issues;
- Conscientious and efficient approach to program writing, validation and organization;
- Fluent English (oral and written).
To find out more about Real please visit www.realstaffing.com