Clinical Biometry

19 hours ago

Bengaluru, Karnataka, India VIATRIS Full time US$ 80,000 - US$ 1,20,000 per year

Role Purpose:

We are seeking a skilled and proactive Clinical Biometry IT Administrator to manage and support our Biometry systems including SAS Server/PC, R studio, CDISC tools, QlikSense tools.

The ideal candidate will have hands-on experience with R, SAS, CDISC, Study Data, system integrations, a strong understanding of GCP & 21CFR part 11 compliance, Knowledge of Clinical Trials and a passion for optimizing Biometry operations through technology including AI.

Role & responsibilities

  1. Understanding and knowledge of specific Biometrics software like SAS and R.
  2. Preferably has worked with these languages. Ability to Write R and SAS programs, De-bug.
  3. Knowledge of R Studio (R Connect, R Workbench, R Package Mgr)
  4. Knowledge of SAS Server and SAS PC
  5. Strong hands-on experience in Documentum D2 (preferably D2 4.x and above) and D2 Life Sciences modules.
  6. Configure Documentum D2LS components including workspaces, widgets, forms, lifecycles, workflows, and security models.
  7. Experience with validating R packages. Knowledge of SAS, R program validation.
  8. Demonstrate competency to install, upgrade and maintain a Statistical Computing Environment for SAS server & PC, R Studio, LSAF, Entimice or similar.
  9. Knowledge of Unix scripting, robocopy commands, Python scripting
  10. Good to have knowledge of Jenkins, Code Commit
  11. Experience with version control systems plus supporting clinical CI/CD processes and data automation pipelines.
  12. Understanding and experience of version control of R, SAS programs and use of tools like with GitLab.
  13. Experience to work in a ICH GCP environment and FDA 21CFR part 11 requirements
  14. Experience implementing and maintaining computerized systems in GCP environments (Development, validation and production environments)
  15. Knowledge of system validation approaches (risk-based validation, CSV documentation)
  16. Understanding and experience with CDISC standards ADaM, SDTM.
  17. Hands on technical knowledge of data conversions, De-bug issues. Supporting tools like Pinnacle and RYZE.
  18. Understanding and experience of Integrations of Biometrics system with File shares via Globalscape/SFTP, external Clinical EDC and Lab systems.
  19. Good to have - Knowledge of visualization tools like QlikSense, Tableau. Build and configure new Qlik Apps, maintain existing apps.
  20. Knowledge of data migrations of Biometry systems and verifications.
  21. Support data/document migration activities from legacy systems to D2LS.
  22. Able to implement and support biometry systems by issue resolution, bug fixes, User access management, Enhancements, Upgrade, maintain adequate storage for File shares, maintain the integrations
  23. Functional Knowledge of clinical trails and study conduct and data analysis & submission in early and late phase clinical studies.
  24. Good to Have Knowledge of AI Predictive/Generative/Agentic