• Provide technical expertise for the conduct of clinical trials. • Support various programming activities related to the analysis and reporting of clinical study data. • May fill the Statistical Programming Lead role on small, non-complex projects. • Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. • Deliver best value and high quality service. • Check own work in an ongoing way to ensure first-time quality. • Produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings. • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance. • Ensure compliance with SOPs/Guidelines, ICH-GCP, and participate in internal/external audits and regulatory inspections as required.

• Provide technical expertise for the conduct of clinical trials • Support programming activities related to the analysis and reporting of clinical study data • Specialize in hematology/oncology/cell therapy • Use SAS programming to produce derived datasets (ADaM), tables, figures, and data listings • Develop and QC derived dataset specifications and other process documents • Ensure complete traceability and regulatory compliance • Participate and contribute to knowledge-sharing sessions

• Act as an internal Subject Matter Expert and work independently to support various programming activities related to analysis and reporting of clinical study data. • Perform as Statistical Programming Coordinator on projects and interact with Sponsors, Data Operation Lead and other functions as a key contact with regard to statistical programming issues. • Use efficient programming techniques to produce and QC of derived datasets and TLF. • Create/modify standard macros and applications to improve the efficiency. • Develop wider knowledge of SAS and other relevant programming languages and processes. • Understand regulatory requirements concerning industry technical standards, maintain all supporting documentation in accordance with WSOPs/guidelines. • Provide relevant training and mentorship to staff and project teams.

• Ability to fill Statistical Programming Lead role on projects • Input into and negotiate statistical programming timelines • Ensure that timelines are adhered to • Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget • Monitor project resourcing, project budgets, and identify changes in scope • Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation • Review statistical analysis plans and mock-shells • Review database set-up specifications • Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities • Interact with sponsors and internal stakeholders with regard to statistical programming issues • Assist project teams in the resolution of problems encountered in the conduct of their daily work • Deliver best value and high quality service • Check own work in an ongoing way to ensure first-time quality • Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings • Produce/QC dataset specifications and other process supporting documents and submission documentation • Ensure quality control (QC) is performed on all process and technical activities related to derived dataset, table, data listing, and figure programming in accordance with corporate quality standards, SOPs/Guidelines, ICH-GCP, and/or other international regulatory requirements • Maintain and expand local and international regulatory knowledge within the clinical industry • Develop knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting, SAS, and processes/procedures within other Parexel functional areas • Provide relevant training and mentorship to staff and project teams • Lead knowledge sharing forums and proactively support the development of the wider department • Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance • Ensure compliance with SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations, and participate in internal/external audits and regulatory inspections as required • Proactively participate in and/or lead process/quality improvement initiatives • Provide consultancy to internal and external sponsors with regard to statistical programming tasks • Represent Parexel at sponsor marketing and technical meetings. • Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity • Represent Statistical Programming on cross-functional technical initiatives • Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions)