• Perform standard non-compartmental pharmacokinetic analyses for Phase I clinical studies • Generate and review PK parameters including Cmax, Tmax, AUC, and half-life • Contribute to PK tables, listings, figures, and summary outputs for clinical study reports • Support analyses across SAD, MAD, and food-effect study designs • Assist with dose proportionality and exploratory PK comparisons where required • Ensure appropriate handling of below-quantification-limit (BQL) data according to SAP guidance • Conduct independent quality control of PK datasets and analysis outputs • Peer review analyses performed by other statisticians or programmers • Document QC findings clearly and support issue resolution in line with SOPs and good statistical practice • Review PK components of protocols and SAPs to confirm feasibility and internal consistency • Ensure analyses are performed according to specifications and document any assumptions or deviations • Support resolution of PK-related analytical queries • Work closely with bioanalytical, clinical pharmacology, clinical operations, and biometrics teams • Support integration of PK outputs into clinical study reports alongside safety and tolerability data • Liaise with programmers, statisticians, and medical writers to ensure traceability and consistency of deliverables • Participate in scientific discussions with internal teams and external sponsors as required • Support knowledge sharing related to PK analysis best practice • Contribute to development and improvement of PK analysis and QC workflows

• Responsible for the application of biostatistical methods to support clinical trials and data management, including statistical planning, design, analysis, and reporting throughout the project life cycle in accordance with project, organizational and regulatory standards. • Act as subject matter expert, providing statistical support to project teams, quality/study auditors, and external stakeholders. • Participate in the promotion of Alimentiv as a global research organization, by contributing to the development, publishing, and reporting of project data. • Lead and develop a group of statisticians and SAS Programmers.