Senior CDA, Senior Statistical Programmer A global CRO.

3.0 - 7.0 years

0 Lacs

ahmedabad, gujarat

On-site

As a Senior Clinical Data Analyst, you will be responsible for creating Data Management Plans (DMP), eCasebook Guidelines (eCCGs), Edit Check Specifications, Data Review Listing Specifications, and other set-up documents. You will also perform User Acceptance Testing (UAT) and review the Electronic Data Capture (EDC) database to ensure data consistency and completeness. Your duties will include Listings Review, Query Management, managing Serious Adverse Events (SAE) and external vendor data reconciliation, analyzing data trends, and generating reports. Additionally, you will be involved in User Account Management, Study Metrics, Quality Control (QC), and EDC Archival. In the role of Senior Statistical Programmer, your responsibilities will include developing, validating, and maintaining programs and tools to generate reports and listings for data review. You will create data transfer specifications, train and mentor other programmers, and establish programming specifications. It will be vital to maintain all necessary programming documentation while adhering to quality and industry standards. You will act as a Subject Matter Expert (SME) for technical inquiries, monitor tasks that may fall within or outside the project scope, and develop, validate, deploy, and manage EDC study builds. Your expertise will be required in crafting tools and macros to enhance quality and efficiency, and your proficiency with industry data standards such as CDASH, SDTM, ADaM, etc., will be crucial. To qualify for this position, you should possess a minimum of 3 to 4 years of relevant experience in the field.,

Posted 2 months ago

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