SUMMARY: Independently applies statistical methodology to ensure that study designs and analyses are statistically valid and meet the recognised international standards.
- Assist sponsors in the design of clinical trials, including statistical sections of the study protocol, randomisation methodology and writing statistical analysis plans.
- Liaise with internal departments, sponsors and other third parties regarding statistical issues and reporting requirements.
- Provide project support to the statistics reporting process through the specification/review of tables, figures and listings shells, writing/review of derived dataset specifications and the formatting of report documents and tabulations.
- Undertake the preparation of final reports, including the production of tables, listings and figures, and report writing.
- 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.
- Make statistical contributions to manuscripts for publication / presentation.
- 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.
- Further develop knowledge of design consultancy and analysis methodology, and statistical software packages (e.g. SAS and nQuery) and regulatory guidance documents e.g ICH, FDA and CPMP points to consider.
- 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 ICH standards and specifically with FDA Quality System Regulation (including 21CFR Part 11).
OTHER SKILLS AND ABILITIES:
- The job holder must be computer literate and numerate with a proven ability to adapt to various computer systems
- Design and analysis consultancy skills and knowledge across a broad range of applications together with key competencies in customer focus, delivering on commitments, building strong relationships, communicating and influencing, and embracing innovation and change.
- Educated to degree level in mathematics, statistics or another subject with a strong statistical component.
- Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.