Senior Statistical Programmer

<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><u><b>Key Accountabilities:</b></u></p><p><b>Project Management:</b></p><ul><li><p>Ability to fill Statistical Programming Lead role on projects</p></li></ul><p>-Input into and negotiate statistical programming timelines. Ensure that timelines are adhered to.<br />-Coordinate and lead a statistical programming team to successful completion of a study within given timelines and budget.<br />-Monitor project resourcing, project budgets, and identify changes in scope.</p><ul><li><p>Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.</p></li><li><p>Review statistical analysis plans and mock-shells.</p></li><li><p>Review database set-up specifications.</p></li><li><p>Interact with sponsors and internal stakeholders with regard to statistical programming issues.</p></li><li><p>Assist project teams in the resolution of problems encountered in the conduct of their daily work.</p></li></ul><p><br /><b>Statistical Programming for Assigned Projects:</b></p><ul><li><p>Deliver best value and high quality service.</p></li><li><p>Check own work in an ongoing way to ensure first-time quality.</p></li><li><p>Use efficient programming techniques to produce/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.</p></li><li><p>Produce/QC dataset specifications and other process supporting documents and submission documentation.</p></li><li><p>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.</p></li></ul><p></p><p><b>Training:</b></p><ul><li><p>Maintain and expand local and international regulatory knowledge within the clinical industry.</p></li><li><p>Develop knowledge of SAS and processes/procedures within other PAREXEL functional areas.</p></li><li><p>Provide relevant training and mentorship to staff and project teams.</p></li></ul><p></p><p><b>General:</b></p><ul><li><p>Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.</p></li><li><p>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.</p></li><li><p>Proactively participate in and/or lead process/quality improvement initiatives.</p></li><li><p>Provide consultancy to internal and external sponsors with regard to statistical programming tasks.</p></li><li><p>Represent PAREXEL at sponsor marketing and technical meetings.</p></li><li><p>Understand regulatory requirements concerning industry technical standards(e.g. CDISC, 21 CFR Part 11, and electronic submissions).</p></li></ul><p></p><p><u><b>Skills:</b></u></p><ul><li><p>Excellent analytical skills.</p></li><li><p>Proficiency in SAS.</p></li><li><p>Extensive knowledge and understanding of the programming and reporting process.</p></li><li><p>Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.</p></li><li><p>Ability to learn new systems and function in an evolving technical environment.</p></li><li><p>Strong project management skills.</p></li><li><p>Strong organizational skills, ability to manage competing priorities, and flexibility to change.</p></li><li><p>Attention to detail.</p></li><li><p>Ability to successfully lead a global team.</p></li><li><p>Work effectively in a quality-focused environment.</p></li><li><p>Effective time management in order to meet daily metrics or team objectives.</p></li><li><p>Show commitment to and perform consistently high quality work.</p></li><li><p>Business/operational skills that include customer focus, commitment to quality management, and problem solving.</p></li><li><p>Demonstrate commitment to refine quality processes.</p></li><li><p>Good presentation skills.</p></li><li><p>Good business awareness/business development skills (including financial awareness).</p></li></ul><p></p><p><u><b>Knowledge and Experience:</b></u></p><ul><li><p>Competent in written and oral English.</p></li><li><p>Excellent communication skills.</p></li></ul><p><br /><u><b>Education:</b></u></p><ul><li><p>Educated to degree level in a relevant discipline and/or equivalent work experience.</p></li></ul>