Sr. SAS Developer
3 days ago
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, ₹2,416,462.14 per year
Benefits:
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund
- Work from home
Work Location: Remote
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