Tasks may include but are not limited to (under the guidance/coaching of a statistical programmer):
* 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.
* Extract information from the system during the course of a trial e.g. summaries, data listings, study data sets.
* 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.
* Perform all activities in compliance with WCT and agreed sponsor quality system standards, relevant GCP standards and specifically with FDA Quality System Regulation (including 21CFR Part 11)
* Provide support in driving system and process improvements to improve the efficiency and quality of clinical study data processing and reporting.
* Validate software, in the role of system tester, and test SAS Macros, maintaining the required validation and testing documentation.
* 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/ statistical reporting and regulatory submission requirements.
* Assist with Quality Assurance and Audit requirements
* Assist the Director of Biostatistics with all other aspects of the job as required
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.
OTHER SKILLS AND ABILITIES:
* The job holder must be computer literate and numerate with a willingness to adapt to various computer systems
* Key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.
* Educated to degree level