Description
* Understand regulatory requirements concerning industry technical standards (e.g. CDISC, 21 CFR Part 11, electronic submissions).Develop, test and run SAS programs for the statistical analysis and reporting of clinical study data. This includes programs for derived datasets, CDISC (SDTM and ADaM) datasets, tables, figures and listings and their validation.
* Ensure the maintenance of documentation e.g. the description of programs and validation
* Produce ad hoc data summaries when requested during the course of a trial.
* Provide project support to the statistics reporting process through the specification of tables, figures and listings shells, writing of derived dataset specifications and the formatting of report documents and tabulations.
* Validate software, in the role of system tester, and test SAS Macros, maintaining the required validation and testing documentation.
* Further develop knowledge of SAS (including BASE, GRAPH, MACRO, ODS, SQL) other software applications (e.g. Excel, Visual Basic, Word). Develop regulatory standards knowledge in computer systems, systems validation, Good Clinical Practice, clinical data management, clinical/ statistical reporting and regulatory submission requirements.
* Assist the Director of Biostatistics with all other aspects of the job as required
* Perform all activities in compliance and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).
Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Your Essential Skills:
-5+ years of relevant Statistical Programming experience.
-Working knowledge of population statistics and analytic techniques
-Experience within an epidemiological, health economics or outcomes research group
-Demonstrable record of collaborative working
-Experience in working with large observational healthcare datasets
-Experience in the pharmaceutical industry
If you are interested in this role, have any questions about this position or would like to register your interest in other positions, please feel free to send your up to date CV or contact Oliver Davies on