FDA STAT GCP Consultant (Jobs in Deerfield, IL)   Requirement id 88275 Job title Consultant Job location in Deerfield, IL Skills required Word And Excel, FDA, STAT, GCP Open Date 06-Feb-2019 Close Date Job type Contract Duration 11 Months Compensation DOE Status requirement not found Job interview type Face to Face interview    Email Recruiter: coolsoft Job Description Consultant: Word And Excel, FDA, STAT, GCP Candidate must be your W2 Employee. We should submitt only GC, GC EAD, L2 EAD, H4 EAD and Citizen. Job Description : Essential Duties and Responsibilities. * Develop programs that convert raw SAS datasets into standard format and improve existing programs by creating standard programs and macros. * Collaborate with manager and other programmers through participation in formal and ad-hoc meetings. * Prepare documentation on all production programming and validation activities; utilize best industry business practices and data standards for clinical data submissions to the FDA and other global regulatory agencies. * Assist manager through contributions to continuous improvement by developing standard programs and macros that follow CDISC guidelines required for regulatory submissions. * Independently program CDSIC SDTM, ADaM datasets. * Map raw data to SDTM (Study data table model) in compliance with CDISC data model standards and create specifications for programming. * Create ADaM Specifications & datasets from SDTM datasets per CDISC analysis data model standards and SAP. * Program data displays (tables, listings, graphs) for inclusion in documents including publications, statistical reports, clinical study reports, and other regulatory documents, as required. * Independently develop QC programs to validate peer programmers SDTM, ADaM datasets, statistical tables, listings, and graphs Qualifications. * Demonstrate proficiency of programming skills. * In-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines * Strong Base SAS v9.2 or later; SAS-STAT, and SAS Macro experience. * Ability to work on multiple tasks and prioritize tasks. * Excellent analytical, problem-solving, organizational, time management, interpersonal and communication skills. * QC experience. Education and/or Experience. * Bachelors degree in Computer Science, Statistics, Engineering or related field plus 5 years of related experience. * Required skills: create SDTM datasets from raw data according to CDISC standards (5 yrs); Create ADAM datasets from SDTM datasets according to CDISC analysis data model standards (3 yrs); Independently write, test, run, document, maintain and QC SAS programs and macros to generate SAS datasets, spreadsheets, data listings, tables and graphical displays of clinical trials data (3 yrs); * Prior experience working with Data Management on edit checks etc is preferred   Call 502-379-4456 Ext 100 for more details. Please provide Requirement id: 88275 while calling.   Other jobs in IL: Chicago (77), Deerfield (7), Des Plaines (2), Downers Grove (7), Downtown Chicago (5), DT Chicago (2), Elk Grove (3), Elk Grove Village (24), Elkgrove Village (1), Evanston (1), Lake Forest (1), Lincolnshire (4), Northbrook (3), Oak Brook (5), Oakbrook (1), Oakbrook Terrace (5), Round Lake (3), Schaumburg (4), South Barrington (1), Springfield (2), Vernon Hills (6), Warrenville (7),    Word And Excel job openings in other states Jobs List Program Monitor/Auditor - 60044 Create date: 16-Feb-2023 Start Date : 03/01/2023 End Date : 11/30/2027 Submission Deadline : 3/31/2023 Client Info : TN DOH Note: * Position Location Hybrid Description : The Lead Program Evaluator is located within the Office of Primary Prevention and works closely w.... 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