Lead Biostatistician

An exciting job vacancy has emerged for a Lead Biostatistician to join one of the world's largest global CROs. This contract research organisation provides support services to many of the biggest names in pharmaceuticals, biotech, medical devices and health care, and has helped to commercialise many leading therapies. This position will be based in London on a permanent basis.

As a Statistical Scientist you will develop statistical methods sections of protocols and review case report forms (CRFs). Prepare analysis plans and write specifications for analysis files, tables, and figures. Communicate with clients regarding study protocol or statistical analysis issues as they arise. Communicate with study team members regarding study execution as it relates to timelines, data quality, and interpretation of results.

Job Responsibilties:

• Coordinate the development of analysis plans, table shells, programming and table specifications, the production of tables, listings and figures, data review and statistical analysis.
• Perform protocol development, sample size calculation, protocol and CRF review and also advise data management staff on database design, and critical data. May advise on validation checks.
• Interpret analysis and craft statistical sections of integrated reports.
• Provide expert statistical input into and review of statistical deliverables (i.e. analysis plans, table shells, programming and table specifications, data review, tables, listings, figures and statistical sections for integrated reports) and data management deliverables (i.e. database design, validation checks and critical data).
• Act as statistical team lead for single complex studies or groups of studies.
• Understand the Scope of Work, budget and quote assumptions, estimate the work completed, manage scope, and provide revenue and resource forecasts for single studies. May manage project budget and resource requirements.
• Perform the review of RFPs and QIPs, prepare proposal text and attend bid defense meetings.
• Manage customer relationships and provide training and mentorship to junior staff members and newcomers.

Skills and Requirements:

• Have excellent written and oral presentation skills including grammatical/technical writing skills and pay attention to the details
• Have in-depth knowledge of applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines Familiarity with moderately complex statistical methods that apply to applicable clinical trials
• Take strong individual initiative, show dedication to quality and present excellent organization skills
• Show deep understanding of SAS computing package
• Be familiar with other relevant statistical computing packages such as nQuery
• Lead effectively multiple tasks and projects
• Lead and co-ordinate small teams
• Solve moderately complex problems
• Establish and maintain effective working relationships with co-workers, managers and clients
• Demonstrate deep knowledge of relevant Data Standards (such as CDISC/ADaM)
• You should have PhD in biostatistics or related field and 1 year relevant experience;
• Master's degree in biostatistics or related field and 3 years relevant experience;
• Bachelor's degree in biostatistics or related field and 5 years relevant experience; or equivalent combination of education, training and experience
• Extensive use of telephone, face-to-face communication requiring accurate perception of speech and of keyboard requiring repetitive motion of fingers
• Regular sitting for extended periods of time
• Flexibility on travelling

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Magenis on + 44 203 854 1050 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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