Senior Statistical Programmer

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 - 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. - 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. 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/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. 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. General - 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. - Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, and electronic submissions). Skills: - Excellent analytical skills. - Proficiency in SAS. - Extensive 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. - Strong project management skills. - Strong organizational skills, ability to manage competing priorities, and flexibility to change. - Attention to detail. - Ability to successfully lead 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. - Demonstrate commitment to refine quality processes. - Good presentation skills. - Good business awareness/business development skills (including financial awareness). Knowledge and Experience: - Competent in written and oral English. - Excellent communication skills. Education: - Educated to degree level in a relevant discipline and/or equivalent work experience.