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 recent 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

📌 Sr. Sas Developer (India)
🏢 Spotline
📍 India