Overview
Work as a statistician on clinical trials; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Working within a reporting team environment, being responsible for assigned statistical and programming aspects of reporting out study results. Excellent team work ethos, and willingness to help others.
Responsibilities
Employees may be required to perform some or all of the following:· Program, validate and QC datasets including SDTMs and complex datasets, e.g. ADQS, ADLB· Program and validate summary tables, listings and complex figures, program statistical analysis tables, according to the SAP, given specifications and pertinent study documentation ,· Create and validate simple dataset specifications for single studies· Write study level SAP text copying from a similar study or amending a standard template· Create project level shells, ensuring templates and standards are adhered to· Simple clinical study under supervision· Manage day-to-day workload to ensure project deliverables are met· Awareness of CDISC standards· Perform sample size calculation for any study· Perform simple simulations with supervision· Create actual randomisation schemes· Work as part of the team producing unblinded outputs· Cross-check results in CSR vs final outputs· Archive own study documentation following instructions in supplied SOPs· Prioritise quality in all activities undertaken, by ensuring the principles in the PHASTAR checklist are followed rigorously, and carefully performing self QC of own work· Implement Good Clinical Practice and adhere to regulatory requirements at all times· Work in a team for furthering statistical research· Assist in development of internal training courses· Being responsible for statistical aspects of deliverables for non-complex deliveries with supervision
Qualifications
· PhD or MSc in Biostatistics or related discipline · Some knowledge of the pharmaceutical industry with an awareness of clinical trial issues. Familiarity with GCP and regulatory requirements.
