Company Name: Pharmaceutical Research Associates, Inc.
Position Title: Clinical Programmer
Hours: Monday – Friday, 8:00 am to 5:00 pm
Location: 9775 Ridge Drive, Lenexa, KS 66219
Produce tables, listings, and datasets to support the analysis of clinical trials by applying SAS programming language to clinical trials data. Perform work in accordance with PRA's policies and standard operating procedures (SOPs) to provide consistent high quality deliverables. Maintain familiarity with the study protocol, the annotated case report forms, and the statistical analysis plans of assigned projects to ensure study tasks are completed in accordance with clinical trial documentation. Work with biostatisticians, pharmacokineticists, medical writers, and other operations staff to generate data summaries. Generate secondary derived SAS datasets and report findings to the lead analysis programmer. Write, document and perform quality control review of programs and command files. Create ad hoc programs to provide information to the project team and client. Contribute to the development of planning documentation for the collection, handling, reviewing and cleaning of clinical data to provide a high quality clinical database. Review, case report forms, data handling guidelines, data edit specifications, and data conversion specifications. Provide input into the statistical analysis plan. Serve as a resource for other functional areas to facilitate project timelines. Review reports for consistency between text and summaries. Integrate database design, documentation, and implementation. Provide estimates of analysis programming work for input into bid proposals and marketing presentations in order to develop competitive and realistic costs. Perform ongoing self-instruction of new computer system features and new SAS programming methodologies.
Bachelor’s degree in Biotechnology, Mathematics, Science, Computer or related field and five (5) years’ experience in the offered role or as a Statistical Programmer, Research Associate, or related role. Employer will also accept a Master’s degree in Biotechnology, Mathematics, Science, Computer, or related field and three (3) years’ experience in the offered role or as a Statistical Programmer, Research Associate, or related role. Three (3) years of experience required with: SAS programming in a clinical field and understanding and implementation of CDISC data models; knowledge of clinical trials. Two (2) years of experience required with: developing analysis datasets and tables, figures, and listings with regard to analysis requirements and timeline; data programming analysis skills; and pharmacokinetic data to support the Pharmacokeneticists with SAS programming needs.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.