Job Description

Job Title: Biostatistician (Cmed CRS)

Reports To: Head of Biostatistics & Statistical Programming

Department: Biostatistics

Core Responsibilities

The provision of expert statistical input and consultancy to Phase 1-4 global clinical trials including design of clinical trials and production of analysis and reporting deliverables on behalf of and/or in conjunction with Cmed clients.

• Provide input as appropriate into all meetings, discussions and activities covering all statistical aspects for assigned trials


• Provide statistical input (as appropriate) into study protocol and CRF to ensure that both documents meet the requirements of the study and of Cmed’s client(s). Ensure adherence to standards (client and/or Cmed), relevant regulatory guidelines and the provision of good statistical practice


• Generate and review randomisation lists and code-break envelopes in accordance with Cmed and/or client procedures


• Provide statistical input to the Data Management Validation Plan to ensure delivery of appropriate high quality clinical data suitable for statistical analysis and reporting


• Author and/or provide input to trial Statistical Analysis Plans. Write detailed statistical methods according to the requirements of the protocol. Prepare table, listing and figure shells in conjunction with the Statistical Programmer(s). Chair analysis planning meetings with internal and external customers (as appropriate)


• Perform ongoing review of clinical data from Cmed/client databases to identify potential issues with data impacting the statistical analysis


• Program and conduct statistical analyses and provide high-quality statistical output for inclusion in clinical trial reports


• Provide expert statistical input to clinical trial reports (as appropriate). Write statistical methods section and review results and conclusions for appropriate statistical interpretation of results.


• Responsible for quality control of all statistical analysis deliverables and quality assurance of programming deliverables provided by the Cmed Statistical Programmer(s) for assigned trials


• Maintain professional and proactive interactions with internal and external customers


• Maintain up-to-date knowledge on statistical techniques and procedures by attendance at professional courses and conferences and by ongoing review of statistical literature


• Review the clinical database for acceptance for statistical analysis prior to database lock (as appropriate)


• Ensure maintenance and appropriate filing of trial statistical documentation for delivery to Cmed clients


• Assist in the development of ‘best-in-class’ analysis and reporting processes to ensure operational efficiency of Cmed Biostatistics’ function


• Support Cmed Senior Biostatisticians in the production of expert statistical input to clinical development programs, ISS, ISE and other forms of integrated statistical analyses.