Job Description
The Biostatistician will act as support or Lead Biostatistician on multiple phase 1 to 4 clinical trials, providing input into the statistical sections of protocols (incl. sample size calculation/validation), Risk-based Monitoring Plans, various Data Management (DM) documents, and statistical sections of clinical study reports (CSRs). The Biostatistician will also ensure the general financial health of clinical trials, develop Statistical Analysis Plans (SAP; incl. Table, Listing, and Figure (TLF) shells), and support teams of Statistical Programmers performing statistical analysis of clinical trial data.
The Biostatistician will work collaboratively within Biostatistics study teams and across departments to produce deliverables of the highest quality possible, within agreed timelines and budget, and in conformance with applicable International Council for Harmonization (ICH) guidelines, Pharmaceutical Industry standards and guidelines, Regulatory Authority requirements and...