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.
Meet milestones as assigned.
Understand and comply with company policies.
Apply SAS programming and analytical skills using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS
Design, develop, evaluate, validate and modify computer programs using SAS to analyze clinical data
Produce and deliver standard datasets, program edit checks, quality tables, figures and listings in a timely and high-quality fashion
Work closely with clinical operations, data management and statisticians to generate statistical output – tables/listing/figures
Liaise with vendors as needed to facilitate electronic data transfers and statistical programming
Master’s degree or higher
5+ years in a pharmaceutical/biotech or CRO setting preferably with Phase III trial experience
Two (2) years minimum experience in Oncology is required
Knowledge of SDTM and ADaM data sets, MACROS, T/L/Gs and CDISC theory and implementation guidelines
R programming experience a plus
Good written and oral presentation skills and ability to communicate effectively
Strong interpersonal, organizational, and multi-tasking skills