Provide statistical programming support for data cleaning and locking activities, and to pre-defined and exploratory analysis.
Following guidance from the study, biostatisticians and create data specifications and analysis programs based on the analysis plan.
Maintain complete and auditable programming documentation.
Essential duties and responsibilities:
8+ years statistical programming experience in healthcare industry. Molecular diagnostics industry experience preferred.
B.S in statistics or related fields
Experience programming in Base SAS.
Experience deriving variables and creating analysis datasets for clinical studies
Knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, HIPAA***
Experience with CDISC, SDTM, and ADaM compliant data sets is strongly desirable
Strong SAS programming and management background along with experience with SAS Base, SAS/Macros, SAS/Graph and SAS/Stat required
Experience in the analysis of complex clinical trial data
Ability to use professional concepts to achieve objectives in creative and effective ways
Experience working with NDA submission experience is highly desirable
Experience with integrated summaries (ISE/ISS) and Clinical Study Reportsss
Base SAS, SAS/MACROS, SAS/ODS, Data management, Data validation, NDA submission, Ad hoc analysis, define.xml, SDTM, ADaMBase SAS SAS/MACROS SAS/ODS Data Management Data Validation NDA Submission Ad Hoc Analysis Define.xml SDTM ADaM