| Principal Statistical Programmer (100% remote) at Remote, Remote, USA |
| Email: [email protected] |
| From: Abhishek Yadav, DMS Vision Inc. [email protected] Reply to: [email protected] Hi, Hope you are doing well !! I have an urgent position. Kindly go through the Job description and let me know if this would be of interest to you. Job Title: Principal Statistical Programmer (100% remote) Location: 100% Remote Duration: 6+ Months Contract Job Description: NOTE: MUST have recently worked on creating ARM for define.xml About the job Support statistical programming activities for clinical studies, ensure statistical programming deliverables are delivered within timelines Manage CRO and review deliverables for accuracy and compliance, performing perform acceptance check and validation Manage, review, and/or execute statistical programming deliverables for planned statistical analysis related to study monitoring, clinical study reports, data integrations, and regulatory query responses, covering multiple studies Generate TFLs to support ad hoc requests Review data management documents (CRF specification, data transfer agreements, DMP, annotated CRF), SDTM and ADaM specification, SAP, and TFL shells to provide statistical programming feedback REQUIREMENTS: 10+ years of statistical programming experience in the pharma/biotech industries Must be able to independently develop SDTM and ADaM specifications (DDT) and program, develop and validate TFLs Recently worked on creating ARM for define.xml, adrg Pinnacle 21 Enterprise experience. Must have worked on a submission within the last year or two Define package experience and ISS/ISE experience Experience leading and managing statistical programming activities for clinical trials and regulatory submissions Strong experience with regulatory submissions activities (BLA/NDA) Vendor and CRO oversight experience If you are interested, please share your updated resume and suggest the best number & time to connect with you. Thanks & Regards Abhishek Yadav DMS Vision Inc. | http://dmsvisions.com/ 4645 Avon Lane, Suite 210, Frisco, TX 75033 Email: [email protected] Keywords: active directory golang Texas |
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| Sat Aug 05 03:16:00 UTC 2023 |