|Job Ref:||204753525||Employer:||cv-library.co.uk||Job Type:||Contract||Country:||United Kingdom||County/State:||Cambridgeshire||City:||Cambridge||Address:||Post Code:||CB1||Post Date:||07/10/2016 03:53|
My Client is currently looking for a Senior Statistician to join there clinical team. Being responsible for statistical input, SAS programming and clinical studies.|
* Act as Representative Statistician on study teams, so as to provide timely input.
* Statistical input from inception through to reporting of Phase I, II and III studies, ensuring high scientific standards for all studies.
* Perform statistical analyses of data and interpret results, ensuring validity of conclusions.
* Respond to regulatory questions regarding submissions
* Prepare and coordinate for blinded data review meetings prior to database lock.
* Perform ad hoc review of data and analyses following unblinding, as required.
* Ensure that appropriate programs are developed for reporting clinical studies (if applicable).
* Perform statistical quality control review and program validation for studies (if applicable).
* Master's degree in Statistics or a subject with a major statistical component with relevant experience (production of statistical analysis plans and statistical reporting/generating TFLs are essential for this role).
* Good knowledge of applicable regulatory requirements and guidelines, e.g. ICH Guidelines.
* Proficient in the use of computers and especially the SAS system.
* Ability to perform and interpret statistical analyses of clinical data.
* Have a good understanding of clinical data, including data quality issues.
* Able to work in a fast-paced, team-oriented environment.
* Possess excellent interpersonal and communication skills (written and verbal).
* Strong attention to detail with a view to bringing studies to a quality conclusion.
* Flexible, positive, creative thinker, good communicator.
* Able to work without close supervision.
* Well-developed time management skills.
For this role, experience in early phase (Phase I/II) with excellent understanding of PK and the statistical reporting/analysis of early phase/PK studies is essential