SAS Programmer
Smith Hanley Consulting Group - Florida

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Smith Hanley Consulting Group, LLC. an inVentiv Health Company, seeks SAS Programmer in Somerset, New Jersey (and other U.S. locations as needed).

Provide critical clinical programming support to projects. Coordinate and provide the technical components required to support the analysis, reporting and decision-making process. Contribute to the development and maintenance of applications used for analysis and reporting purposes. Collaborate with Global Programming Leader or external partners through ADMIRe, ensuring partners have thorough understanding of expectations via reverse knowledge transfer. Contribute to the outsourcing of any reporting aspects of a project and provide the operational link for these technical reporting activities between MedImmune and partners, e.g. CRO's and Marketing Companies. Interact directly and independently with Biostatisticians, Data Management, Programmers, Clinical Development staff and management as a fully functioning member of the clinical programming team. Proactively keep the manager updated on the status, programming accomplishments and criticality of any issues impacting the quality and timely delivery of SAS Programming outputs. Actively solicit feedback from manager to address any issues and/or complex problems. Provide accurate estimates on timelines. Lead in the development of analysis data set specifications. Independently implement and champion the use of standards and TA specific data listings, summary tables, and figures as specified in statistical analysis plan in the clinical study report. Develop robust, flexible SAS macro programs or modules that generate standard outputs and/or facilitate CDISC implementation. Ensure compliance of standards for all SAS programming assignments. Proactively offer and provide SAS programming and analytical skills that support clinical trial and/or TA projects and programs. Act as internal resource for advice and guidance with respect to SDTM requirements. Inventory, review, and document source and derived datasets from legacy studies that will be part of a NDA submission. Review all SDTM deliverables, including mapping specifications, datasets, annotated CRFs to SDTM, and define.xml. Coordinate internal reviews of all SDTM deliverables, including documentation of findings from all reviewers. Compile data conversion issues that are identified and their resolutions. Provide QC and SAS programming support to the validation of SDTM datasets, ADaM datasets Support the production of datasets and TFLs that are part of the NDA submission.

Requires Bachelor's degree in Mathematics, Statistics, Public Health or related field, plus 5 years of clinical trial programming experience using SAS within pharmaceutical, biotechnology, and/or contract research organization industries. At least one year experience in SDTM data mapping, creation, and verification. Experience with ISS/ISE as well as ADaM. Advanced SAS programming skills with proficiency in Base SAS, SAS/STAT and SAS/Graph. Ability to develop standard SAS macros. Working knowledge of CDISC guidelines. Working knowledge of FDA regulations and GCP/ICH guidelines as related to clinical programming processes. Knowledge of medical terminology and clinical trials methodology. Understands data interoperability across and amongst the Clinical Data Management applications and all externally collected data. Understand study design documentation (eCRF design, eCRF annotations, DB structures, SAPs and SPPs). Must be willing to travel to client sites and work locations as needed.

Must also have authority to work permanently in the U.S.

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