Description

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:<ul><li>Ability to fill Statistical Programming Lead role on projects</li></ul>-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.<ul><li>Coordinate project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation.</li><li>Review statistical analysis plans and mock-shells.</li><li>Review database set-up specifications.</li><li>Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities.</li><li>Interact with sponsors and internal stakeholders with regard to statistical programming issues.</li><li>Assist project teams in the resolution of problems encountered in the conduct of their daily work.</li></ul>Statistical Programming for Assigned Projects:<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/QC derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings.</li><li>Produce/QC dataset specifications and other process supporting documents and submission documentation.</li><li>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.</li></ul>Training:<ul><li>Maintain and expand local and international regulatory knowledge within the clinical industry.</li><li>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.</li><li>Provide relevant training and mentorship to staff and project teams.</li><li>Lead knowledge sharing forums and proactively support the development of the wider department.</li></ul>General:<ul><li>Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance.</li><li>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.</li><li>Proactively participate in and/or lead process/quality improvement initiatives.</li><li>Provide consultancy to internal and external sponsors with regard to statistical programming tasks.</li><li>Represent Parexel at sponsor marketing and technical meetings.</li><li>Assessment of technology and processes, to facilitate best practices and increase quality, efficiency, and productivity.</li><li>Represent Statistical Programming on cross-functional technical initiatives.</li><li>Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions).</li></ul>Skills:<ul><li>Excellent analytical skills.</li><li>Advanced knowledge of SAS programming techniques.</li><li>Extensive knowledge and understanding of the programming and reporting process.</li><li>Good knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable local and international regulations such as 21 CFR Part 11.</li><li>Knowledge of the efficacy endpoints and analysis techniques specific to the disease being treated.</li><li>Ability to learn new systems and function in an evolving technical environment.</li><li>Strong project management skills.</li><li>Strong organizational skills, ability to manage competing priorities, and flexibility to change.</li><li>Attention to detail.</li><li>Ability to successfully lead and mentor a global team.</li><li>Work effectively in a quality-focused environment.</li><li>Excellent time management in order to meet daily metrics or team objectives.</li><li>Show commitment to and perform consistently high quality work.</li><li>Strong business/operational skills that include customer focus, commitment to quality management, and problem solving.</li><li>Demonstrate commitment to refine quality processes.</li><li>Good presentation skills.</li><li>Ability to negotiate and influence in order to achieve results.</li><li>Good business awareness/business development skills (including financial awareness).</li><li>Client-focused approach to work.</li><li>Good negotiation skills.</li></ul>Knowledge and Experience:<ul><li>Competent in written and oral English.</li><li>Excellent communication skills.</li><li>Proven record of successfully leading teams in a statistical programming environment.</li></ul> Education:<ul><li>Educated to degree level in a relevant discipline and/or equivalent work experience.</li></ul>

Principal Statistical Programmer

Description

Parexel