Statistical Programmer II Job at cGxPServe, Albany, NY

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  • cGxPServe
  • Albany, NY

Job Description

Responsibilities:
  • Team provides customized real-world data and real-world evidence solutions to address the most important research questions across clinical development, market access, and commercial use cases for our life sciences partners.
  • Independently translate analytic specifications from a statistical analysis plan into R code to create analytic datasets, generating descriptive and inferential statistics, data visualizations, often involving Client variables or complex statistical methods, in consultation with the study principal investigator.
  • Serve as subject matter expert on appropriate use cases for, and nuances of, the variety of different Flatiron data modalities, including EHR-derived real-world data, clinico-genomics data, ML-extracted data, and claims data.
  • Develop a proficient understanding of cancer biology, therapy, and/or epidemiology across multiple major tumor types and appropriately apply this understanding when crafting analytic code.
  • Provide mentorship and support to more junior statistical programming staff.
  • Collaborate with cross-functional stakeholders across our medical and scientific organization to execute and deliver on client-sponsored research studies in an accurate, effective, and timely manner.
  • Contribute to continuous improvement of Flatiron's proprietary analytical tooling and templates, at times acting as liaison to the relevant teams and stakeholders.
  • Continue to develop a deeper understanding of real-world data and related methodologies used to generate real-world evidence.
  • Work closely with Epidemiology and Biostatistics to assure output quality by providing expert feedback on SAP, Analytic/TLF specifications from functional perspective.

Requirements:

  • Doctorate degree (e.g., PhD, ScD, DrPH) in Biostatistics/Statistics, Data Science, Bioinformatics, Biological Sciences, Public Health, Math, or a closely related field with 3-4 years of relevant experience, or a Master's degree with 6-7 years of relevant experience or a bachelor's cdegree with 7-8 years of relevant experience.
  • In addition, you're an analytical thinker and excellent communicator with experience analyzing real-world data (e.g., healthcare claims or electronic health records).
  • Excellent programmer in R (including tidyverse) and are proficient working in Git-based environments (e.g., Github, Gitlab).
  • Solid experience in creating Tables, Listings, and Graphs using R packages.
  • Create/review programming documents (e.g., programming plan, specification for datasets and output template).
  • Knowledge of ICH guidelines, FDA / EMA / other regulatory authority guidance from a programming standpoint.
  • Extensive experience with large healthcare-related datasets (e.g., administrative claims, electronic medical records, genomics).
  • Experience leading teams, either as a manager or project/team lead.
  • Familiar with CDISC conventions, i.e. SDTM and ADaM models (using SAS) and related controlled terminologies, and knowledge or some experience using these models.

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