Apply Now: Scientist, QPP
4 weeks ago
Job Description (JD) for Scientist, QPP Role: Summary of Job Responsibilities: - Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements. - Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications. - Performs Integral data management, data cleaning process, and integration with Phoenix WinNonlin® software. - PK/PD analysis using Phoenix WinNonlin® 8.1 or higher software, in accordance with study specifications. - Plays an active role in planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality deliveries. - Creates Tables, Listings, and Figures (TLFs), and summary reports for regulatory submission. - Perform quality control and quality assurance of PK deliverables as per the client assignment specifications. - Should be proactive to pursue advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives. - Co-ordinates with the Client POCs for clarity of specifications, data issues, reviews, schedules, etc. - Co-ordinates cross-functional activities involving statisticians, SAS® programmers and medical writers involved in pharmacokinetic projects. - Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and client’s SOPs. Qualifications and Experience: Minimum Education: - Master of Pharmacy (M. Pharmacy) / in Pharmacology/Pharmaceutics/Pharmaceutical technology Minimum Work Requirements: - 4-6 years of hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using Phoenix WinNonlin® software. - Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts. - Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications. - Should have good academic credits and excellent communication skills (oral and written). Skills: - Expertise in Phoenix WinNonlin® software in creating workflows independently. - Demonstrated strong understanding of Drug Discovery and Development, PK/PD principles, physiology/pharmacology and biopharmaceutics through scientific presentations, posters, and publications. - Proficiency in Medical and Scientific writing. - Proficient in using GraphPad Prism, R Programming and SAS® software. - Thorough knowledge regarding International Conference on Harmonisation-Good Clinical Practice. Basic Knowledge regarding Clinical Trials Methodologies
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Scientist, QPP
4 weeks ago
India Cytel Full timeJob Description (JD) for Scientist, QPP Role:Summary of Job Responsibilities: Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements.Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications.Performs Integral data management, data cleaning process, and...
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Scientist, QPP
3 days ago
India Cytel Full timeJob Description (JD) for Scientist, QPP Role: Summary of Job Responsibilities: Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements. Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications. Performs Integral data management, data cleaning process,...
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[Only 24h Left] Scientist, QPP
4 weeks ago
India Cytel Full timeJob Description Job Description (JD) for Scientist, QPP Role: Summary of Job Responsibilities: - Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements. - Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications. - Performs Integral data management,...
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Applied Data Scientist
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India Taskify AI Full timeJob Description Role: Applied Data Scientist Location: Remote We are hiring applied data science professionals to drive a high-impact analytics initiative. In this short-term contract role, you'll work with complex datasets to uncover insights, build statistical models, and guide business decisions without the overhead of production ML engineering. What...
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Scientist, QPP
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India SAIVA AI Full timeABOUT SAIVA AI SAIVA AI applies machine learning to make optimal use of electronic health data for the most vulnerable healthcare population. Our mission is to improve patient outcomes by augmenting clinical decision-making with the power of AI. Based in Silicon Valley, our team is a group of passionate healthcare technology veterans, engineers, and data...
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▷ Apply Now! Staff Data Scientist
4 weeks ago
India Commonwealth Bank Full timeJob Description Organisation: At CommBank, we never lose sight of the role we play in other people's financial wellbeing. Our focus is to help people and businesses move forward, to progress. To make the right financial decisions and achieve their dreams, targets and aspirations. Regardless of where you work within our organisation, your initiative, talent,...
