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