Statistical Programmer III

Katalyst CRO; Raleigh (NC); On-site; USD 130,000 - 180,000; Full time

Job summary

Katalyst CRO in Raleigh, NC seeks a senior statistical programmer to translate SAPs into R code, create analytic datasets, and generate descriptive and inferential statistics using real-world data.

You will work with EHR-derived data, claims data, and clinico-genomics data, mentor junior staff, collaborate with cross-functional teams, and help improve Flatiron‑style analytical tooling and templates.

Qualifications

• PhD or equivalent in Biostatistics/Statistics/Data Science or related field with relevant experience.
• Analytical thinker with experience analyzing real-world data (claims or EHR).
• Excellent programmer in R (tidyverse) and proficient with Git-based environments.
• Strong experience creating Tables, Listings, and Graphs using R packages.
• Knowledge of ICH guidelines and regulatory guidance in programming.
• Experience with large healthcare datasets (claims, EHR, genomics).
• Leadership experience or ability to lead teams or projects.
• Familiar with CDISC SDTM/ADaM models (using SAS) and related terminologies.

Responsibilities

• Translate analytic specifications from a SAP into R code to create analytic datasets and perform descriptive/inferential statistics.
• Generate data visualizations and reports, often involving client variables or complex methods.
• Serve as SME on Flatiron data modalities (EHR, clinico-genomics, ML-extracted data, claims).
• Mentor junior statistical programming staff and collaborate with cross-functional teams.
• Contribute to tooling and templates, liaising with relevant teams for improvements.
• Develop understanding of real-world data and methodologies for real-world evidence.
• Ensure output quality by providing feedback on SAP and analytic specifications.

Skills

R

tidyverse

descriptive statistics

inferential statistics

data visualization

communication

mentoring

Education

PhD or equivalent in Biostatistics/Statistics/Data Science

Master's degree with 6-7 years of relevant experience

Tools

Git-based workflows

SDTM/ADaM (SAS)

Job description

• 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

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