Job Description

Position Summary

The Biometrics and Clinical Pharmacology Application Support Team Member will provide technical and functional support for applications used in clinical data management, biostatistics, pharmacokinetics/pharmacodynamics (PK/PD), and regulatory submissions. This role ensures smooth operation of critical systems supporting biometrics and clinical pharmacology functions, enabling high-quality data analysis and compliance with industry standards.

Key Responsibilities

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.
Job Type: Full-time

Pay: ?2,010,884.06 - ?2,416,462.14 per year

Benefits:

Health insurance Paid sick time Paid time off Provident Fund Work from home
Work Location: Remote