Biostatistician IV needs 5+ years in a pharmaceutical/biotech or CRO setting preferably with Phase III trial experience
Biostatistician IV requires:
- Master’s degree or higher
- Knowledge of SDTM and ADaM data sets, MACROS, T/L/Gs and CDISC theory and implementation guidelines
- R programming experience a plus
Biostatistician IV duties:
- Provide input in the design and development of clinical trial protocols, case report forms and clinical databases
- Prepare Statistical Analysis Plan/table shells and write specifications for analyses.
- Provide statistical support in the development of papers and presentations.
- Perform statistical analysis according to the SAP, validate analysis programs, review TFLs, prepare statistical methods and results sections for the clinical study report (CSR), provide statistical insight into interpretation and discussion of study results.
- Interact with vendors providing clinical support.