Be part of our empowered Parexel Statistical Programming team today!Principal Statistical Programmer (with SDTM experience) to contribute to meaningful advances that benefit patients in need.Location Home based USAs a Principal or Senior Programmer you will be recognized as a subject matter expert, providing technical support and expert advice to internal and external sponsors.
Parexel will provide you with the perfect opportunity to expand on your experiences and develop new skills in a stimulating work environmentKEY RESPONSIBILITIES include (not an exhaustive list of duties):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 budgetMonitor project resourcing, project budgets, and identify changes in scopeEnsure quality control (QC) on all process and technical activities related to derived dataset, table, listing, and figure programming in accordance with corporate quality standardsMaintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory complianceProvide a broad range of leadership and influencing capabilities to achieve the business objectives and goals for both Parexel and sponsorsProvide leadership, project specific training, stakeholder management, external sponsor support,resource management, and project management for the required programming tasks supporting clinical trial activities Qualifications SkillsProficiency in SASKnowledge of the programming and reporting processKnowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical applicationStrong leadership skillsAbility to successfully work together with a (“virtual”) team (including international teams as required) as well as independentlyExcellent analytical skillsEffective time management in order to meet daily metrics or team objectives EducationEducated to degree level in a relevant discipline and/or equivalent work experienceLanguage SkillsExcellent communication skills both verbal and writtenRequired skills and experience:5 plus years proficiency in SAS programming2+ years of ADaM, CDISC or SDTMLead experience in a Pharma settingAttention to detail, ability to be self-driven and solid organization skillsExcellent communication skills (verbal and written) EEO Disclaimer Parexel is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.