Planet Pharma's client is a global CRO providing full-service drug development services to the pharmaceutical and biotechnology industries - from early-phase and bioanalytical sciences through Phase II and III trials. RESPONSIBILITIES
- 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.
- Liaise with internal departments, sponsors and other third parties to ensure all delivery requirements fulfil client needs.
- 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.
- Provide support in driving system and process improvements, and to develop and implement solutions 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.
- 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 with Quality Assurance and Audit requirements
- Assist the Director of Biostatistics with all other aspects of the job as required
- 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).
- Educated to degree level.
- The jobholder has SAS programming skills with knowledge in SAS/Macro, Proc Report and ODS. Good working knowledge in SAS/Graph, Proc SQL.
Fatlum Topallaj| Planet Pharma Recruitment Consultant
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