Statistical Programmer I

**When our values align, there's no limit to what we can achieve.**   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. **Key Accountabilities**: **Project Management** * Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation. **Statistical Programming for Assigned Projects** * 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 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. * Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation. **Training** * Maintain and expand local and international regulatory knowledge within the clinical industry. * Develop knowledge of SAS and processes/procedures within other Parexel functional areas. * Provide relevant training and mentorship to staff and project teams as appropriate. **General** * Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulator 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 process/quality improvement initiatives. * Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). **Skills:**  * Excellent analytical skills. * Proficiency in SAS. * Knowledge and understanding of the programming and reporting process. * Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11. * Ability to learn new systems and function in an evolving technical environment. * Ability to manage competing priorities and flexibility to change. * Attention to detail. * Ability to successfully work as part of a global team. * Work effectively in a quality-focused environment. * Effective time management in order to meet daily metrics or team objectives. * Show commitment to and perform consistently high quality work. * Business/operational skills that include customer focus, commitment to quality management, and problem solving. **Knowledge and Experience**: * Competent in written and oral English. * Good communication skills. **Education:** * Educated to degree level in a relevant discipline and/or equivalent work experience.