Application Support-Support

8 hours ago

Bhubaneshwar, Odisha, India Spotline, Inc. Full time
  • Application Support & Maintenance
  • Provide day-to-day support for biometrics and clinical pharmacology applications (e.g., SAS, NONMEM, Phoenix WinNonlin, Spotfire, RStudio, and related tools).
  • Troubleshoot issues, resolve incidents, and escalate complex problems to vendors or IT teams.
  • Monitor system performance and ensure uptime for critical applications.
  • User Support & Training
  • Act as the first point of contact for end-users in biometrics and clinical pharmacology teams.
  • Conduct training sessions and create user guides for supported applications.
  • Assist with onboarding new users and managing access rights.
  • Data & Workflow Management
  • Support workflows for clinical trial data integration, statistical analysis, and PK/PD modeling.
  • Ensure compliance with data standards (CDISC, SDTM, ADaM) and regulatory requirements.
  • Collaborate with biometrics teams to streamline data pipelines and reporting.
  • Governance & Compliance
  • Maintain audit trails, documentation, and SOPs for application usage.
  • Ensure systems meet GxP, 21 CFR Part 11, and other regulatory compliance standards.
  • Participate in validation and qualification of new tools or upgrades.
  • Collaboration
  • Work closely with biometrics, clinical pharmacology, IT, and QA teams to align support with business needs.
  • Coordinate with vendors for patches, upgrades, and issue resolution.
  • Contribute to cross-functional projects involving data science, AI/ML, and advanced analytics.

Qualifications

  • Bachelor's degree in computer science, Life Sciences, Bioinformatics, or related field.
  • At least 5 years of experience in application support, preferably in pharmaceutical or biotech environments.
  • Familiarity with biometrics and clinical pharmacology workflows (statistical programming, PK/PD modeling, data visualization).
  • Hands-on experience with tools such as SAS, NONMEM, Phoenix WinNonlin, R, Python, Metworx, or similar.
  • Knowledge of regulatory compliance (GxP, 21 CFR Part 11, HIPAA).
  • Strong problem-solving, communication, and stakeholder management skills.

Preferred Skills

  • Experience with cloud-based environments (AWS, Azure, SAS).
  • Understanding of clinical trial data standards (CDISC, SDTM, ADaM).
  • Exposure to DevOps practices for application deployment and monitoring.
  • Ability to work in a fast-paced, cross-functional team environment.

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