This inclusive employer is a member of myGwork – the largestglobal platform for the LGBTQ+ business community. Key AccountabilitiesProject Management:Ability to fill Statistical Programming Lead role on projectsInput into and negotiate statistical programming timelines. Ensure thattimelines are adhered to.Coordinate and lead a statistical programming team to successfulcompletion of a study within given timelines and budget.Monitor project resourcing, project budgets, and identify changes inscope.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 tostatistical programming issues.Assist project teams in the resolution of problems encountered in theconduct of their daily work.Statistical Programming For Assigned ProjectsDeliver 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 supportingdocuments and submission documentation.Ensure quality control (QC) is performed on all process and technicalactivities related to derived dataset, table, data listing, and figureprogramming in accordance with corporate quality standards,SOPs/Guidelines, ICH-GCP, and/or other international regulatoryrequirements.TrainingMaintain and expand local and international regulatory knowledge withinthe clinical industry.Develop knowledge of SAS and processes/procedures within other PAREXELfunctional areas.Provide relevant training and mentorship to staff and project teams.GeneralMaintain all supporting documentation for studies in accordance withSOPs/Guidelines to ensure traceability and regulatory compliance.Ensure compliance with SOPs/Guidelines, ICH-GCP, and any otherapplicable local and international regulations, and participate ininternal/external audits and regulatory inspections as required.Proactively participate in and/or lead process/quality improvementinitiatives.Provide consultancy to internal and external sponsors with regard tostatistical programming tasks.Represent PAREXEL at sponsor marketing and technical meetings.Understand regulatory requirements concerning industry technicalstandards(e.g. CDISC, 21 CFR Part 11, and electronic submissions).SkillsExcellent analytical skills.Proficiency in SAS.Extensive knowledge and understanding of the programming and reportingprocess.Knowledge of SOPs/Guidelines, ICH-GCP, and any other applicable localand international regulations such as 21 CFR Part 11.Ability to learn new systems and function in an evolving technicalenvironment.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 teamobjectives.Show commitment to and perform consistently high quality work.Business/operational skills that include customer focus, commitment toquality management, and problem solving.Demonstrate commitment to refine quality processes.Good presentation skills.Good business awareness/business development skills (includingfinancial awareness).Knowledge And ExperienceCompetent in written and oral English.Excellent communication skills.EducationEducated to degree level in a relevant discipline and/or equivalentwork experience. Show more Show lessTagged as: remote, remote job, virtual, Virtual Job,virtual position, Work at Home, work from home