East London Postnatal Doula & Newborn Care Expert
Core
Senior statistical programmer developing clinical trial data sets, listings, tables, and graphs for pharmaceutical sponsors using SAS and R.
Role type
Senior IC statistical programmer (clinical development)
Builds
SDTM, ADaM datasets, reviewer's guides, define.xml files, complex listings, tables, and graphs for clinical trials
Domain
Biopharmaceuticals / Clinical Development / Biostatistics
Required skills
SAS programming, CDISC standards (SDTM, ADaM, Define.xml), clinical trial methodologies, FDA/ICH regulations, statistical analysis, data validation, regulatory submissions
Preferred skills
R, Python, pharmacokinetic data, neuroscience field, Unix/Linux, git
Responsibilities
Generate SDTM, ADaM specifications and datasets; Develop SAS programs for complex listings, tables, and graphs; Validate and maintain SAS/R programs; Oversee CRO statistical programming deliverables; Support clinical study reports and regulatory submissions; Create and maintain programming standards and SOPs
Seniority
Senior, hands-on IC