Principal Statistical Programmer

As a member of Parexel's Statistical Programming group, you will be heavily involved in leading trials to successful completion, working in close collaboration with sponsor teams, and Parexel teams in differing locations. Depending on your career goals, you will be provided the opportunity to be exposed to a variety of different sponsors, products and therapeutic areas, or choose to focus your career on working with a specific sponsor and gaining in depth knowledge of a specific therapeutic area and compound. You will become a part of a team with an inherent breadth of knowledge and expertise in small, single center Investigator studies to multi-site, multi-national trials in Phases I to IV of clinical development, as well as observational studies. From initial planning meetings at the study design stage through to implementation and execution, our team of skilled statistical programmers will employ industry-accepted statistical tools and techniques, as well as innovative consulting, to provide the quality and efficiency of projects. Parexel develops and delivers cost effective, high-quality training programs for those employees that are directly involved with sponsor functional partnerships to ensure that our statistical programmers can quickly step in to make significant contributions to the success of a study. In addition, you will receive the opportunity to shape your development through quarterly conversations with your manager. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below. Full Time Travel: Minimal Glassdoor Reviews and Company Rating Success Profile Check out the top traits we're looking for and see if you have the right mix. Team player Tech-Savvy Communicator Proactive Detail-oriented Analytical Rewards Global Impact We are one truly global team working together to propel each client´s journey ahead faster. Balance We value work-life balance. We try and keep regular hours and an emphasis on life outside the office. Development Opportunity to learn and grow through a performance and development goal-setting program. Collaboration Work with industry leaders and subject matter experts. Variety Opportunity to work on a wide range of therapeutic areas and medical devices. The Principal Statistical Programmer will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors, and works independently to support various programing activities related to the analysis and reporting of clinical study data. In addition, the Principal Statistical Programmer can fill the Statistical Programming Lead role on projects and liaise with sponsors, Biostatistics Leads, Data Management Leads, and other functional areas as required. Further, the Principal Statistical Programmer will monitor quality, timelines, resource allocation, and productivity in relation to budgets. Job Qualifications: 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. Provide leadership, project specific training, stakeholder management, external sponsor support, resource management, and project management for the required programming tasks supporting clinical trial activities. Interact with sponsors and internal stakeholders with regard to statistical programming issues. Assist project teams in the resolution of problems encountered and 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. Experience: Candidates must have minimum of 8+ years of statistical programming in clinical/pharma domain. Strong programming and analytical skills using SAS software. Good knowledge and understanding of CDISC SDTM, ADaM and Define.xml standards & TLF's. Proven knowledge of regulatory guidance documents, Proven understanding of clinical trials, fundamentals of clinical research, GCP. Strong communication (verbal and written) & interpersonal skills Good team player, self-disciplined & self-motivated with ability to learn faster. Education: A Masters in statistics, mathematics, or another relevant discipline. Or B.Sc., Life Science Graduates/ Statistics Graduate/ SAS certified preferable. #LI-REMOTE