Remote _ Statistical Data Scientist
Contract City: Cambridge State: Massachusetts Visa: No H1B Description: Statistical Data ScientistSummaryLooking for statistical data scientist with statistical training and relevant experience in a pharmaceutical setting. Key skill sets include clinical trial experience, statistics training, CDISC knowledge, R/Shiny experience, R package development experience.EducationMaster's or PhD degree in statistics, computer science, data science or related quantitative discipline Required Skill SetsWorking knowledge of R programming, Shiny app developmentWorking knowledge of clinical trial design and implementation3+ years of experience building production R Shiny apps and R packages3+ years of experience (CRO or Pharma) creating CDISC datasets and TFLs for regulatory submissionExperience and preference for Tidyverse packagesKnowledge and experience with statistical and analytical techniques and visualizationsExperience with Posit/RStudio pro products is preferredExperience with version control systems (e.g., GIT)Highly desirable skill setsExperience with EDC systems (e.g. medidata RAVE) desirable R package/code Validation experience Published GitHub code repositories, R packages, Shiny apps strong plusFamiliarity with ICH E9 and 21 CFR Part 11 and other clinical trial regulationsExperience with IT system qualification and R validation for regulatory submissionExperience with R validation SOP writing and collaboration with IT/QA Experience with GxP environment/system validation/risk assessmentFamiliar with software testing, including unit and system level testingLinux OS, Python, HTML, JavaScript, CSS, D3, CI/CD, devops, parallel computing, AWS, statistics, computer system validation experience and skills are plusesExperience with administration of Posit professional productsLinux administration and shell scripting, Kubernetes, Openshift, Digital security, cybersecurity training, Networking experience preferredExperience with Cloud computing platforms Git expertise + CI/CD and devops pipelines