A leading CRO is urgently looking for a Permanent Senior Statistician in Cambridge and other locations throughout UK. In addition to multiple locations, an excellent benefits scheme will be available for the right candidate and we also have multiple start dates on offer.
The role would require the right candidate to act as the lead statistician on selected multiple projects, overseeing the statistical aspects of clinical trials from design, through analysis and reporting. Furthermore, they would also be required to support the lead statistician on other projects and to provide programming and QC support in the production of statistical appendices. Lastly, the candidate will be expected to represent the Biostatistics department within the company and with interactions with client companies and regulatory agencies, as required.
If you have the required experience for this position and are eligible to work in the UK then please call Maria Latif immediately on 020 7922 7138 and email your CV to [log in to unmask]
KEY ACTIVITIES:
-Be familiar with and follow the departmental and company standard operating procedures (SOPs) and working practices (WPs)
-Assist in the training and implementation of departmental procedures for the Biostatistics team
-Serve as a lead statistician on selected multiple projects
-Ensure projects are well documented consistent with company SOPs and working practices
-Contribute to the leadership of project teams as assigned by Biostatistics Management. This involves conducting team meetings, maintaining project timelines, assessing resource need, providing resources, and budget management. Ensure that SOPs are being followed and that appropriate project documentation is ongoing
-Time management of own and team's time spent on projects
-Interact with the sponsor on statistical aspects of the project and present at meetings as required
-Where applicable provide the Project Manager, Biostatistics department and company management with timely, accurate status and resourcing reports
-Produce sample size calculations. Provide input into study design and statistical considerations, during protocol development. Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Contribute to writing appropriate protocol sections
-Serve as the randomization statistician on selected projects
-Lead the development and review of statistical analysis plans, including table, listing and graph specifications
-Specify the general structure of the analysis database following industry guidelines oversee its development, and ensure completeness for use in all programming
-Organize and produce statistical analyses and statistical appendices, with appropriate documentation
-Validate and review statistical analyses and statistical appendices, with appropriate documentation
-Prepare and review Statistical Reports, Integrated Summaries of Safety, Integrated Summaries of Efficacy and other documents, as required. Contribute statistical methods section for Integrated Clinical Statistical Reports. Review Integrated Clinical Statistical Reports
-Oversee the Quality Review of the statistical reporting on selected projects
-Provide Senior Review on selected projects
-Mentor members of the department, providing project guidance and statistical advice
-Contributing to department documents or policies, input into SOP and WP development and revision, and
training of new employees
-Contribute to process improvement and department initiatives
-Contribute to the general infrastructure support to the Biostatistics department
-Act as the representative of the department to other divisions
-Assist in bidding and business development activities, as required
REQUIRED EXPERIENCE:
-Provided Lead Statistician role on studies in a clinical trial environment and demonstrated the ability to contribute to
the Biostatistics project leadership
- Strong knowledge of statistical principles underlying clinical trials and strong statistical skills
-SASĀ® programming skills and familiarity of other statistical packages (e.g. StatXact, Nquery) and understanding of
database structures
-Good organizational skills across individual projects, managing own and team workloads. The ability to adapt and
adjust to changing priorities.
-Excellent written and verbal communication skills.
-Ability to work in a multi-disciplinary team setting.
-Demonstrated initiative, motivation and problem solving skills.
-Positive attitude and the ability to work well with others
REQUIRED QUALIFICATIONS:
-Advanced degree (MSc or PhD) in statistics, or related field. BSc qualifications will be considered with good
relevant industry and statistical experience.
If you have the required experience for this position and are eligible to work in the UK then please call Maria Latif immediately on 020 7922 7138 and email your CV to [log in to unmask]
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