• 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