Biostatistical Programming Senior Associate
Core
Perform hands-on statistical programming to support complex data analysis of clinical studies and regulatory submissions.
Role type
Senior IC biostatistical programmer
Builds
Clinical study analysis datasets (SDTM, ADaM) and regulatory submission documents
Domain
Biotechnology / Clinical Development
Required skills
SAS/STAT, CDISC SDTM, CDISC ADaM, CDISC Define, clinical trial data manipulation, data quality validation, regulatory submission documentation
Preferred skills
R, Python, automation platforms, open-source tools, prior regulatory submission experience
Technologies
SAS, R, Python
Responsibilities
Create and validate complex SDTM and ADaM datasets; Prepare statistical programming specifications and regulatory documents; Collaborate with global cross-functional teams to validate data quality programs; Assist Study Lead Programmer tasks
Seniority
Senior, hands-on IC
