AVANCE CLINICALAvance Clinical is a Global Contract Research Organisation which offers specialised services supporting drug development for the pharmaceutical and biotechnology industry.Broad PurposeAs a member of the Biometrics-Stats team, the Biostatistician is responsible for preparing, analysing and interpreting statistical data to ensure accurate reporting of results from clinical study data. The role assists with the experimental planning and design of clinical trials.Core ResponsibilitiesProvide statistical advice on study design.Provide statistical input in the development of study protocols.Prepare/review statistical plans and randomization schedules.Prepare/review listings, tables and figures for clinical study reports.Perform/review statistical analyses.Perform internal review of statistical methodology and results sections of clinical study reports.Liaise with Data Management team about data transfer, and the review of Case Report Forms and Data Management Plans.Assist with pharmacokinetic analyses.Liaise with bioanalytical laboratories about data transfer.Assist with preparation and review of clinical study reports.Participate in client meetings.Other duties as directed by Line Manager or delegate.Qualifications, Skills and ExperienceHigher degree in relevant discipline to Biostatistics / Pharmacokinetics (highly desirable).Minimum 2-3 years experience in statistical analysis in pharmaceutical / health research.Working knowledge of ICH GCP Guidelines, medical terminology and clinical trials processes.SAS programming experience (highly desirable).Understanding of pharmacokinetics (highly desirable).Ability to communicate at a high level with clients, senior management and other stakeholders.Excellent oral and written communications skills including the ability to prepare reports and procedures.Excellent organisational skills with the ability to set priorities, analyse problems, formulate clear and effective solutions and coordinate a number of tasks simultaneously.Proven ability to deliver tasks on time and with a high degree of accuracy.Ability to work under pressure in a multi-disciplinary team environment.Demonstrated initiative, trust and reliability and the ability to work unsupervised.Intermediate to advanced MS Word and Excel.BenefitsReputable growing CRO with stability.A diverse and inclusive culture with a strong emphasis on team collaboration.Training and career development opportunities.Attractive remuneration.
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