Senior Statistical Programmer

Job Title

Develop and validate internal/external R packages for clinical trial analysis (ADaM, tables, figures, listings)

Build complex R-Shiny applications (dashboards, animations) to address clinical questions, Health Authority requirements, and decision-making

Conduct statistical programming of clinical data using R

Create and/or validate safety and efficacy study outputs (ADaM, TLFs) consistent with data definitions, protocol, SAP, and aCRF

Collaborate with statisticians and peers to ensure quality, accuracy, and submission readiness of clinical data (SDTM, ADaM, TFLs, define.xml)

Identify problems and develop tools/solutions that improve efficiency and capacity of the Statistical Programming group

Lead R implementation and support/train other Biostatistics team members where needed

Strong, hands-on programming skills in R and R-Shiny; proven ability to reproduce statistical analyses using R

Strong data visualization and data wrangling skills using R; proficiency with R packages for data exploration and visualization

Solid application of statistical methodology and concepts in clinical trial analysis

Advanced knowledge of CDISC industry standards (SDTM/ADaM) and standard program development practices

Prior Data Scientist experience, demonstrating the ability to apply programming skills within broader data science and clinical contexts

Exposure to Late Phase, Real-World Evidence (RWE), and Global Medical Affairs studies is highly desirable

SAS proficiency is a plus but not mandatory; R is the primary and non-negotiable skill requirement