Senior Principal Biostatistician
- Experience Level
- Experienced (non-manager)
- Experienced Senior Principal Biostatistician required to work for Covance
- Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials
- This is a permanent full-time role, either office based or home based inGermany, Spain or UK
- You must have previous experience of working as a Principal Biostatistician in either a biotech, CRO or pharma company within Europe
Join our growing team and discover your extraordinary potential by working as a Covance Senior Principal Biostatistician. You will enjoy a varied role working for different sponsors across severaltherapeuticareas, leading projects and mentoring junior members of the department.The position offers an excellent support network with access to Covance's statistical consultants, flexible working solutions and the opportunity to progress your career. If you are looking to strengthen your expertise within a varied and dynamic environment, then this is a fantastic opportunity.
Job Primary Functions
- Actasstatisticalconsultant for clients and Covance s
- Coordinatebiostatisticalaspects of submissionstoregulatoryauthorities; participate in presentations to regulatory reviewers.
- Provide training on biostatistics-relatedtopicsto otherdisciplines.
- Demonstrateexcellentproblem-solving skills, a proactive approach and the ability to make sound decisions on a regular basis and to communicate these cl
- Provide ongoingguidance and mentoring within the department to ensure thorough knowledge of the processes used and ongoing technical developmen
- Providesupportfor special committees, e., DMCs,including input/review of charters, andensuring maintenance of appropriate blinding.
- Developandmaintainclose working relationships with other disciplines, particularly those who interact closely with Bi
- Identifyand participate in the assessment and implementation of new technologies or of new applications for existing ones.
- Maintainawareness of new developmentsin discipline-relatedtechniques, which may be applied to the management and reporting of clinical trial
- Supervisionofless-experienced biostatisticianswithinproject activities.
- Biostatisticsleadfor large global or other major
- Ensure mechanismsin placeto maintainflowofappropriateinformation between disciplines on project tea
- Responsiblefordevelopmentof StatisticalAnalysis Plans, to includestatisticalmethodology, statistical programming procedures, definition of derived variables, data-handling rules and mockups.
- Responsiblefor Biostatistics deliverables within assigned projects.
- Developand coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific proj
- Statistical analysisof clinical trial data and related decision-making.
- Responsiblefor statistical inputtostatisticalreportsandClinical StudyAuthorizes final reportsas one of Covance signatories.
- Provide statisticalguidanceindevelopmentof clinicalresearch program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signat
- Provide statisticalinput into design/review of format of CRFs.
- Preparerandomizationspecifications; generate schedules; verify randomization components (specification and schedule). Provide input into planning activities related to the preparation of, distribution of and access to randomization and unblinding informat
- Determinedocumentationrequirements for Biostatistics aspects of projects. Give guidance to support business and regulatory requirements including definition of appropriate documentation, storage/communication media, and retention/return of documents at study close-out.
- Independentpeerreview of statistical deliverables, e., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
- SASprogrammingand related activities for the presentation and analysis of clinical trial
- Contribute to review andamendmentof departmental processes and supporting document
- Projectmanagementactivities for identified projects including financial, resource planning and utilization, timelines and milestone management.
- Contactwithclient across multiple d
- Contributeto proposalactivities andclientpresentation
- Represent thedepartment during
- Masters or PhD in a statistical discipline.
- Previous experience of working as a Principal Biostatistician in either a biotech, CRO or pharma company.
- Interpersonal and effective communication skills.
- Cooperative, team-oriented and proactive.
- Ability to motivate others.
- The ability to work to tight deadlines while maintaining high standards.
- SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data and survival analysis.
- Ability to adhere to strict guidelines and codes of practice.
- A good knowledge of the overall Clinical Trial process and of its application within Covance Clinical Development.
- Competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of trials.
- Ability to explain statistical concepts to non-statisticians.
- Supervisory and organizational skills.
- A proactive approach to management of day-to-day activities and actions that may affect Covance as a business.
- A professional approach at all times.
- Fluent in English language (both verbal and written).
PLEASE NOTE CANDIDATES WHO DO NOT FULFIL THE CRITERIA MAY NOT RECEIVE A RESPONSE
NO AGENCIES PLEASE
MORE INFORMATION AVAILABLE ON REQUEST
For a confidential discussion about this opportunity, please phone Peter Lewis on+44 (0) 1628 543 457. To apply, please click on the APPLY button.
Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you'll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.For more information on Covance please visit:www.covance.com.
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