Biostatistician II (Clinical Trial Experience Required)

What You'll Do: As the lead Biostatistician on the studies assigned, perform the following tasks: Act as primary statistical contact for internal and external project team members. Communicate and work with Biostatistics management to maintain the project budget and timelines. Review case report forms (CRFs) and completion instructions Give input to database design and data edit considerations necessary to collect and clean data Develop, or assist in the development of, Interim Analysis Plans (IAPs) and Statistical Analysis Plans (SAPs) as needed per the protocol Develop program specifications – SDTM and ADaM dataset specifications and mock tables, listings and figures (TLFs) – needed to perform the analysis defined in the IAP/SAP Perform the statistical analysis by independently programming derived datasets and TLFs and validate the developer’s corresponding programs per department SOPs Develop or review statistical methods and results sections of statistical reports, clinical study reports (CSRs), or publications Assist in planning and designing clinical studies, including: overall study design development outcome / endpoint determination power analysis / sample size estimation reports randomization and blinding procedures development statistical methods section development in the protocol Develop, or assist in the development of, Randomization Plans and randomization programs or lists Carry out all activities according to CTI SOPs and project-specific conventions within th