East London Postnatal Doula & Newborn Care Expert
Core
Senior/Principal Statistical Programmer working on clinical development programs for pharmaceutical clients, generating datasets, tables, and reports for regulatory submissions.
Role type
Senior/Principal Statistical Programmer (Biostatistics)
Builds
Clinical trial data summaries, regulatory submissions, and statistical analysis results
Domain
Pharmaceutical / 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
Technologies
SAS, R, Python, Unix/Linux, git
Responsibilities
Generate SDTM, ADaM specifications, datasets, reviewer's guide and define.xml files; Develop SAS programs for datasets, listings, tables, and graphs; Deliver high-quality statistical programming results; Oversee CRO programmers' deliverables; Support preparation of clinical study reports and regulatory submissions; Understand and follow FDA regulations; Contribute to creation and validation of programming standards; Participate in development of CRFs and data validation plans; Provide review/author data transfer specifications; Collaborate with internal and external functions; Provide review/author SOPs for statistical programming practices
