• Manage the statistics support to one or more projects/sponsor programs of work • Provide expert review of study designs, analysis plans, and reports • Assist sponsors in the design of clinical trials • Provide project support to the statistics reporting process • Prepare final reports, including the production of tables, listings, and figures • Develop, evaluate, and run Statistical Analysis System (SAS) programs

• Develop scoring rules & program algorithms for COA measures • Provide statistical support for new COA measures & endpoints • Collaborate with data scientists on digital measure validation • Participate in thought leadership and publish research papers

• Perform data extraction, cleaning, validation, transformation, and maintenance across multiple data sources. • Conduct statistical analyses and quantitative data mining to identify trends, patterns, anomalies, and other meaningful insights. • Develop reports, dashboards, summaries, and visualizations to communicate analytical findings. • Compile, validate, interpret, and present data to support operational and business objectives. • Perform statistical programming and data analysis using analytical software and programming languages. • Design and execute database queries to retrieve and analyze data from large datasets. • Prepare clear, concise, and accurate reports, memoranda, data files, and presentations for internal and external stakeholders. • Communicate analytical methods, assumptions, and results to both technical and non-technical audiences. • Support internal quality reviews, audits, and data validation activities. • Participate in team projects, methodology discussions, and continuous process improvement initiatives. • Stay current on statistical methods, healthcare industry trends, data analytics technologies, and applicable regulations. • Perform ad hoc analyses and other duties as assigned. • Maintain compliance with all applicable privacy, security, and confidentiality requirements. • Adhere to IntegrityM policies and client requirements governing the protection of sensitive information.

• 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