What are the responsibilities and job description for the Statistical Programmer II position at Katalyst CRO?
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.
- 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 degree 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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