| SAS Clinical Trial Consultant at Remote, Remote, USA |
| Email: [email protected] |
|
http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=308970&uid= From: Raveena Mourya, DMS Visions Inc [email protected] Reply to: [email protected] Hi, Hope you are doing well, Please find the job description given below and let me know your interest. Position: SAS Clinical Trial Consultant Location: 100% REMOTE Duration: FULL TIME Job Description: DESCRIPTION MAJOR RESPONSIBILTIES/ACTIVITIES Develop, test and execute SAS programs to produce and validate CDISC SDTM and ADaM datasets, tables, figures and listings (TFL). Perform review and provide guidance on the development of the clinical database specification, data transfer agreement/specification, specification of tables, figures and listings (TFL) s. Develop and review specification for SDTM datasets and ADaM datasets for safety data, TFL s and other specifications, e.g. patient profiles, OPS reports. Develop and review electronic data submission package (SDTM annotated CRF, define.xml, Study/Analysis Data Reviewer's Guide) for high complexity studies. Serve as a programming project lead on a complex study (e.g. adaptive design, integrated safety/efficacy study) to distribute and oversee tasks for the programming team, communicate with internal and external clients, plan and execute delivery, and manage resources and competing project priorities effectively. Ensure budget and scope of project work remain aligned. Manage the study documentation flow as per Worldwide SOP and other procedural documentation including timely document submission to eTMF. Be able to describe and explain Worldwide documentation and eTMF requirements. Contribute to department process improvement including creating and testing standard SAS Macros, maintaining the required validation documentation. Provide consultancy to Clinical Data Managers, Statistical Programmers and Biostatisticians on programming, clinical and analysis data standards (CDISC) and electronic data submission requirements. Develop and provide Statistical Programmers with training and coaching on the Biostatistical Operations department process, infrastructure and tools, collaboration with other internal and external parties and the role of the statistical programmer. Develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) and other software applications (e.g. Excel, Visual Basic, Word). Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical Practice, clinical data management, clinical/statistical reporting and regulatory submission requirements etc. Act as subject matter expert for internal and external quality audits and inspections. Ensure all activities performed by the study team are in compliance with Worldwide 3 and sponsor quality requirements, relevant ICH and regulatory authority standards, e.g. FDA 21 CFR Part 11, General Data Protection Regulation (GDPR). Act as a mentor for junior department members Thanks & Regards, Raveena Mourya Email: [email protected] | Phone : 972-325-9476/Extn.112 Linked In: linkedin.com/in/raveena-mourya-766314250 DMS Vision, INC 4645 Avon Lane, Suite 210 Frisco, TX 75033 http://dmsvisions.com/ Keywords: Texas http://bit.ly/4ey8w48 https://jobs.nvoids.com/job_details.jsp?id=308970&uid= |
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| 01:09 AM 26-Jan-23 |