Primarily working with the Data Managers, Statisticians and Clinical Project Managers on ongoing clinical studies to assure results are consistent with expectations, and quality control procedures are followed
Participating in the creation and review of key statistical documents including but not exclusive to:
Case Report Form
Data Specifications
Data Transfer Agreements
Statistical Analysis Plan
Tables, Listings and Figures Shells
CDISC Mapping Documentation
Liaising with Statisticians and Data Management and Biostatistics Managers at regular intervals to discuss progress and any issues outstanding
Liaising with personnel at the sponsor company, or their designates, with Central Event Adjudication Committees, Data Safety Monitoring Committees or any other third parties involved in statistical programming activities
Deriving and adapting data for analysis, producing patient listings, summary tables, figures and patient profiles, as part of SAS Programming
Producing or participating in the validation of SDTM Domains based on the provided Specifications, including Pinnacle 21 execution, producing or reviewing SDTM Specifications, SDTM reviewer guides, Define.XML, and any other documentation required for SDTM derivation, producing or participating in the validation of ADaM Datasets based on the provided Specifications, including Pinnacle 21 execution, producing or reviewing ADaM Specifications, producing ADaM Reviewer guides, Define.XML, and any other documentation required for ADaM derivation, as part of CDISC Mapping
Training other project team members to make full and correct use of the company procedures and Biostatistics Reporting Environment
Applying company standards, and actively participating in improvements towards harmonization and standardization across projects
Participating as necessary in sponsor audits, regulatory authority inspections, and other third-party meetings
Performing necessary administrative functions
Entering and updating data in relevant CTMS modules
