Provide statistical leadership and collaborate with clinical researchers in the design of clinical trials, selection of clinical endpoints, estimation of sample size, and development of protocol and case report forms for phase I- III clinical trials.
Ensure accuracy of reports and consistency among mock shells across studies.
Assist in designing statistical analysis plans and table/figure/listing shells in accordance with study protocol.
Demonstrate understanding of statistical concepts and methodologies.
Generate integrated summaries of safety and efficacy analyses to support regulatory submissions.
Provide inputs on study design and statistical methods.
Assist in development of randomization schedule, sample size estimation.
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.
Participate in and co-ordinate the Statistical Programming review of Case Report Forms (CRFs), annotated CRFs, database structures and study related documentation (e.g. data validation guidelines).
Ensure accuracy of reports and consistency among mock shells across studies.
Assist in SAS programs and output for the management of clinical trial data, the tabulation of data, preparation of patient data listings, graphical output, and creation of derived datasets and statistical analysis of data as specified in the Statistical or Report Analysis Plans.
Review CRFs, data collection procedures, and quality plans, edit check specifications, and
participate in data management discussions.
Develop statistical analysis plans, perform statistical analyses, and author clinical study reports.
Development and implementation of standardized TFLs.
Generate integrated summaries of safety and efficacy analyses to support regulatory submissions.
Other responsibilities as delegated by reporting head & senior management.
Location : UK/Europe
