Statistical Programmer II

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;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.</p><p>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&#39;re committed to making a difference.</p><p></p><p></p><p><b><u><span>Key Accountabilities</span></u></b><u><span>:</span></u></p><p></p><p><b>Project Management</b></p><ul><li>Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.</li></ul><p></p><p><b>Statistical Programming for Assigned Projects</b></p><ul><li>Deliver best value and high quality service.</li><li>Check own work in an ongoing way to ensure first-time quality.</li><li>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.</li><li>Assist in the production/QC of derived dataset specifications and other process supporting documents and submission documentation.</li></ul><p></p><p><b>Training</b></p><ul><li>Maintain and expand local and international regulatory knowledge within the clinical industry.</li><li>Develop knowledge of SAS and processes/procedures within other Parexel functional areas.</li><li>Provide relevant training and mentorship to staff and project teams as appropriate.</li></ul><p></p><p><b>General</b></p><ul><li><span>Maintain all supporting documentation for studies in accordance<br />with SOPs/Guidelines to ensure traceability and regulator </span>compliance.</li><li><span>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.</span></li><li>Proactively participate in process/quality improvement initiatives.</li><li>Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).</li></ul><p></p><p><b><u>Skills:</u></b><b> </b></p><ul><li>Excellent analytical skills.</li><li><span>Proficiency in SAS.</span></li><li>Knowledge and understanding of the programming and reporting process.</li><li>Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.</li><li>Ability to learn new systems and function in an evolving technical environment.</li><li>Ability to manage competing priorities and flexibility to change.</li><li><span>Attention to detail.</span></li><li>Ability to successfully work as part of a global team.</li><li>Work effectively in a quality-focused environment.</li><li>Effective time management in order to meet daily metrics or team objectives.</li><li>Show commitment to and perform consistently high quality work.</li><li>Business/operational skills that include customer focus, commitment to quality management, and problem solving.</li></ul><p></p><p><b><u>Knowledge and Experience</u></b>:</p><ul><li>Competent in written and oral English.</li><li>Good communication skills.</li></ul><p></p><p><b><u><span>Education:</span></u></b></p><ul><li>Educated to degree level in a relevant discipline and/or equivalent work experience.</li></ul><p></p><p></p><p></p>