Ashley Clarke @ RBW Consulting is for a recruiting for a specialist contract research organisation (CRO) to the pharmaceutical industry for an experience biostatistician. They are an award winning company focusing on working with the leading pharma and biotech companies around the world. Their company ethos is centred around building a collaborative working environment to ensure they are providing the best support for both their staff and clients. The company are really engaged with in the lives of people they are ultimately striving to help. They offer their clients very flexible services, in turn this creates lots of different career development paths for its staff.
· Provides support across all assigned statistical tasks during the lifecycle of the project, from protocol to CSR.
· Prepares Statistical Analysis Plans (SAPs), including the development of well-presented mock-up displays for tables, listings, and figures. collaborate with the sponsor, if required.
· May be responsible for the statistical aspects of the protocol, generation of randomization schedule, publications and input to the clinical study report.
· Coordinates the activities of other biostatistics and statistical programming personnel on assigned projects to ensure timely completion of high quality work. Provides independent review of project work produced by other biostatisticians in the department.
· Creates or reviews programming specifications for analysis datasets, tables, listings, and figures.
· Reviews SAS annotated case report forms (CRFs), database design, and other study documentation to ensure protocol criteria are met and all data is captured as required to support a high quality database and the planned analysis.
· Conducts and participates in verification and quality control of project deliverables, ensuring that output meets expectations and is consistent with analysis described in SAP and specifications.
· Implements company objectives, and create alternative solutions to address business and operational challenges.
· Serves as biostatistics representative on project teams, interfacing as necessary with other departmental project team representatives. This would include preparing in advance for internal meetings, contributing ideas, and demonstrating respect for opinions of others.
· Manages scheduling and time constraints across multiple projects, sets goals based on priorities from management, adapts to timeline or priority changes by reorganizing daily workload, and proactively communicates to biostatistics management any difficulties with meeting these timelines.
· Monitors progress on study activities against agreed upon milestones and ensures the study timelines for project deliverables are met. Identifies out of scope tasks and escalate to management.
· Provides statistical programming support as needed.
· May participate in Data Safety Monitoring Board and/or Data Monitoring Committee activities, including charter development and serving as an independent non-voting biostatistician.
· May lead projects involving integrated analyses, attend regulatory agency meetings or respond to questions, as needed, to support the statistical analysis results of clinical trials on behalf of the sponsor.
· Follows applicable SOPs, WIs, and relevant regulatory guidelines (e.g. ICH).
· Maintains well organized, complete, and up-to-date project documentation, and verification/quality control documents and programs; ensuring inspection readiness.
· Displays willingness to work with others and assists with projects and initiatives as necessary to meet the needs of the business.
· Supports business development activities by contributing to proposals, budgets, and attending sponsor bid defence meetings.
· Coaches and mentors other Biostatistics staff.
· Graduate degree in biostatistics or related discipline.
· Moderate experience in clinical trials or an equivalent combination of education and experience.
· Proficiency in programming.
· Ability to apply knowledge of statistical design, analysis, relevant regulatory guidelines, and programming techniques utilized in clinical research and to effectively communicate statistical concepts.
· Experience across all statistical tasks required to support clinical trials during the lifecycle of the project, from protocol to CSR.
· Excellent written and verbal communication skills.
To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Ashley Clarke on +44 (0) 1273 952 363 and send your CV through using the apply button on this page.
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