Dear All Stat Member,
My client is one of the largest specialist biometrics CROs is widely recognized as providing its customers with specialist services in CRF Design, Data Management, Statistics, Medical Writing, Quality Assurance and Electronic Data Management Systems
As a Sr. Statistician you will work with clients in developing study protocols, provide advice on design options, sample size considerations etc. You will also be responsible attending external meetings, e.g. with health authorities, KOLs, steering committees, DSMBs etc.
As a lead statistician you will be responsible for multiple projects and will be accountable for quality, timelines, budget, production of TFLs for clinical study reports - work with our client's programmers and support statisticians on correct interpretation of the SAP; develop and validate programs, in particular for statistical analyses
Experience and Qualification Required
• Post-graduate qualification MSc, PhD in statistics or a related discipline
• Around 5 years' clinical trials experience as a biostatistician in the pharmaceutical industry or in a CRO
• Awareness of GCP requirements - should have received GCP training in the last 12-18 months, must have worked to SOPs and maintained trial documentation
• Has worked on study design / sample size calculations / protocol development, preferably for early phase studies
• Experienced in translating medical problems into statistics
• Preparation and QC of analysis plans, including the preparation of table and listing shells ("mock tables") is an integral part of this job, and our client is looking for someone who has done this for at least 3 years
• Prior experience of leading study teams in the production of tables, figures and listings for clinical study reports, especially validation and quality control (QC) aspects
• Experience with several therapeutic areas, with preference for oncology - other areas may be cardio-vascular, CNS, PK
• Good familiarity with commonly used statistical methods, such as ANOVA/ANCOVA, linear mixed effects models, survival analysis, sample size calculations, multiple comparisons, handling of missing data, dose-proportionality, bio-equivalence, non-parametric methods, etc.
• Must have good knowledge of SAS; knowledge also of other statistical packages would be an advantage
I also have a role for statistician with around 2-3 years experience within a CRO framework. To discuss this and other roles, please contact [log in to unmask] or call 02032862529
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