Main Job Tasks and ResponsibilitiesLeads the statistical analysis of a clinical study in compliance with the analysis plan and protocol Provides high quality statistical support direct to our clients whilst managing projects Provides statistical and methodological input for sample size calculation and protocol development Develops a detailed statistical analysis plan and related mock shells Performs quality control and senior review of the tables, listings, figures, datasets, inferential analysis and statistical text Leads Data Review Meetings Writes statistical reports and / or sections for the integrated study report, reviews the draft study report, and ensures that all data presented is correct Responsible for project scope, efficiencies, milestones and budgets and completing work according to CRO SOPs Expert person, central reviewer of ADaM datasets, deliverables and processes, keeping abreast with all regulatory developments within CDISC Contribute to the development, implementation and maintenance of the quality system and suggests process improvements Assists in providing input into RFPs and bid defense meetings BiostatisticoCRO internazionaleEducation and ExperienceAdvanced Degree in sciences, with substantial statistics component At least eight years of experience as a statistician in life science / pharmaceutical / CRO environment Proven organizational and problem solving / decision making skills Expert knowledge of the applicable regulatory guidance Proficient in SAS software Proficient in Microsoft Office (e.
g. Word, Excel, Outlook) Fluent in English and local language(s) Good communication skills Advantageous, project management and leadership skills An international, full service CRO, is looking for an experienced Statistician to join our team in Europe.
We are looking for an experienced statistician to support our growing team of statisticians and programmers. You will work on varied therapeutic areas, be given the opportunity to work on a group of studies for a single client (leading to increasing responsibility and implementing efficiencies), providing analysis and expertise and as a key study team member you will have direct contact with our clients.
There will also be opportunities to support the Management Team in organising and executing the departmental process initiatives and may also be the opportunity to act as the Project Lead Statistician on groups of customer studies.
Additional, you may also have the opportunity to train and develop less experienced Statisticians and Programmers. Ottima opportunità di carriera.