Clinical Data Manager

Primary Responsibilities
?Statistical programming for clinical trials, including CRF and clinical database design
?Development and validation of EDC systems
?Statistical programming support for the implementation of data models and the reporting of clinical trials
?Statistical analysis (via analysis datasets, tables, figures, listings, etc.) using an appropriate statistical analysis system (i.e. SAS®)
?Data Management – Helps ensure the accuracy and consistency of data flow from case report forms (CRFs) and database definitions, through to and specifications for analysis datasets
?Compliance with CDISC standards
Qualifications
?Bachelor’s degree in a quantitative or scientific field
?5 years of statistical programming experience.
?Experience in CRF and clinical database design
?Experience performing statistical analyses on data required.
?SDTM and/or ADaM experience is required, specifically creating/authoring specifications for SDTM and/or ADaM datasets.
?Experience with TFLs (tables, figures, and listings) or TLGs (tables, listings, and graphs) is required.
Experience within pharma or CRO required. CRO experience preferred.