Subject Matter Experts (SME)

Analyst - SEND

Xybion India are looking for Analyst – SEND, part of SEND Intelligence Services (SEND-IS) team supporting for nonclinical study data conversion into SEND format and fulfills the requirements set in CDISC-SENDIG & FDAsdTCG.

Roles and responsibilities:

  • Non-clinical study data conversion into SEND format.
  • Study data assessment and identifying data gaps/discrepancies in the study reports.
  • Data extraction, recreation, reformatting and generation of SEND datasets using Xybion tools & systems.
  • Perform QC of the SEND dataset and assure SENDIG & sdTCG compliances.
  • Preparation of Define file, nSDRG & Xybion summary report as service deliverables.
  • Develop in-depth knowledge of Pristima & Savante and its applications.
  • Customer-centric support for SENDIG implementation services to Xybion customers.
  • Learn & understand the current regulatory requirements and standards set by FDA & CDISC for non-clinical study data submission.
  • Knowledge transfer and mentor new starters/team members.
  • Encompass cross-functional support as and when needed.
  • Provide feedbacks/suggestion for product enhancements as an end-user of Xybion products.
  • Perform other duties as assigned and ensure the quality of deliverables and work in fast-paced manner meeting the targets.

Technical Skillsets:

  • Real-time experience in understanding of nonclinical/clinical study data.
  • In-depth knowledge on CDISC standards (SDTM/SEND) & FDA-sdTCG requirements and its compliances.
  • Knowledge on any nonclinical data collection/management systems (Pristima, PDS, & Provantis).
  • Knowledge on drug discovery, GXPs (GLP/GCP) regulations and associated requirements for electronic records and good documentation practices.
  • Computer Knowledge & Proficiency with MS Office, Word, Excel & PowerPoint.
  • Minimum 2-5 years of real-time experience in either nonclinical/clinical study data collection & management.

Educational Qualification:

  • Bachelors degree in Engineering, Technology, Computer Application (BE/BTech/MCA) in Computer Science (CS) / Information Technology (IT).
  • UI / UX Development Certification preferred.

About Xybion

Xybion is the leading provider of software, services and consulting for global corporations operating in highly regulated industries. Xybion specializes in the development and delivery of flexible enterprise solutions that can be easily configured, integrated or deployed out of the box to deliver the capabilities you need. Leveraging our extensive global experience working with companies of all sizes, we offer deep domain knowledge of FDA regulations and have a long track record of helping clients build effective compliance and risk mitigation strategies and solutions.

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