Description
An excellent opportunity has arisen for an experienced Statistician to join a global pharmaceutical company on a 12 month contract basis, based in Basel.
RESPONSIBILITIES AND TASKS
*Responsible for all biostatistical aspects of the project and/or trial, the statistician is assigned to.
*Interacts with authorities statisticians to set and/or defend decisions on statistical issues for the project, the statistician is assigned to.
*Informs and suggests solutions to the statistics head on critical issues within the project.
*Discusses protocol and CRF with the authors and members of the clinical team/clinical trial team.
*Plans details of the randomization schedule with the appropriate members of the project team.
*Ensures that the trial design is compatible with the trial objectives.
*Reviews and approves protocol and CRF prior to their use or submission to approval committees.
*Verifies the appropriateness of the planned analysis and writes or supervises the writing of the trial analysis plan.
*Assesses the impact of subjects withdrawn/lost to follow-up and of the deviations from planned trial design.
*Assesses the impact of deviations from distribution assumptions, lack of homogeneity of treatment arms, possible outliers etc.
*Assists in programming and/or validation where appropriate.
*Performs or supervises statistical analyses and discusses the results and the presentation of the results with appropriate team members
*Writes or supports the writing of the statistical section/module of reports (FSR, integrated safety/efficacy reports and publications). Reviews and approves the reports.
*Maintains up-to-date project and trial documentation including that of presentation and analyses.
*Verifies adherence to statistical standards and SOPs within the project.
*Supports and leads continuous development and improvement of statistics and programming processes
*Ensures appropriate statistical planning, analysis and reporting of one or more assigned clinical studies, development programs or drug submission dossier
*Performs role of mentor for statisticians, statistical programmers and trainees
*Reviews and anticipates resource requirements for existing projects
*Provide resource plans and timelines for deliverables for assigned projects
*Provide statistical education to other functions
*Maintain / develop a high standard of statistical methodology
REQUIRED QUALIFICATIONS AND EXPERIENCE
*University degree (or equivalent) in mathematics, statistics or related disciplines.
*Deep knowledge and expertise in statistics and its applications to clinical trials.
*Good knowledge of statistical software (at least SAS®) and of data management principles and tools.
*At least five years' experience as statistician in clinical development in pharmaceutical industry or clinical research organizations.
*Knowledge of international clinical research regulations and requirements.
*Ability to work efficiently in an international team environment.
*Excellent interpersonal and communication and management/coaching skills.
*Must be able to work according to timelines and achieve project deadlines.
*Fluent English.
For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk
