Principal Accountabilities:

• Quality assurance of statistical deliverables of other Biostatisticians within the department.


• Provide statistical consultancy to clients with regards to design of clinical development programs and/or 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).


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


• 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 an/or publications (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 and/or projects.


• 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


• 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


• Responsible for the specification, programming and statistical reporting of integrated summaries, including ISS, ISE, CER and other meta-analytic techniques.


• Generate cost estimates for statistical activities in response to client requests


• Perform budget tracking for assigned trials and alert Head of B&SP to potential cost overruns/out of scope activities. Ensure project and resource tracking sheets are accurate and updated as required.


• Provide input to the appraisal process when required.


• Provide input into recruitment process including interviewing.


• Ensure timesheets are accurate and updated on a weekly basis.

Essential Work Experience and Qualifications

• Minimum of a masters (M.Sc.) or equivalent in Medical Statistics in conjunction with at least four years experience in the application of statistics in clinical trials at a CRO or pharma company.


• At least two year’s experience in programming and reporting inferential statistical analyses using SAS.


• Expert knowledge of global clinical trial practices, procedures and methodologies (including regulatory guidelines relating to biostatistics).


• Experience of project managing (timelines and/or budgets) of statistical activities.


• Strong oral and written communication skills (including the ability to communicate statistical concepts and information to non-statisticians)

Attributes Include:

• Good organisational skills, plus an understanding of resource & budgeting.


• High quality interpersonal and communication skills and the ability to operate effectively in a global working environment.


• Work calmly under pressure and meet deadlines.


• Professional, positive and enthusiastic attitude.


• A thorough understanding of medical terminology, clinical trial methodology, drug development process and ICH/GCP.


• A strong investigative and meticulous approach to all activities and tasks.


• Transparent approach, clear and precise.


• Team player


• The ability to delegate tasks.


• Assist improving the effectiveness of the organisation such as developing new processes, systems and client relations.


• Work effectively and efficiently with internal partners in Cmed.