- Experience Level
- Experienced (non-manager)
- Experienced Lead Biostatistician required to work for Covance as a Principal Biostatistician
- 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 anywhere in Europe
- You must have previous experience of working as a Lead Biostatistician in either a biotech, CRO or pharma company
Join our growing team and discover your extraordinary potential by working as a Covance Principal Biostatistician. You will enjoy a varied role working for different sponsors across several therapeutic areas, 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 Lead expertise within a varied and dynamic environment, then this is a fantastic opportunity.
Job Primary Functions
- Biostatistics lead for large global or other major projects.
- Provide statistical input into other disciplines' activities and participate in interdepartmental processes.
- Provision of technical solutions and advice to Covance staff and to clients on statistical methodology and principles.
- Supervision of less-experienced biostatisticians within project activities.
- Ensure mechanisms in place to maintain flow of appropriate information between disciplines on project team.
- Training and development of less-experienced staff within the department.
- Responsible for development of Statistical Analysis Plans, to include statistical methodology, statistical programming procedures, definition of derived variables, data-handling rules and mockups.
- Responsible for Biostatistics deliverables within assigned projects.
- Develop and coordinate QC procedures for Biostatistics deliverables, ensuring activities are appropriate for effectively and efficiently delivering quality output within specific project.
- Statistical analysis of clinical trial data and related decision making.
- Responsible for statistical input to statistical reports and Clinical Study Authorizes final reports as one of Covance signatories.
- Provide statistical guidance in development of clinical research program and in design of individual studies as part of multi-disciplinary team; responsible for statistical input to protocol; approves protocol as signatory.
- Provide statistical input into design/review of format of CRFs.
- Prepare randomization specifications; 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 information.
- Determine documentation requirements 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.
- Independent peer review of statistical deliverables, e.g., protocols, Statistical Analysis Plans, Tables, Figures and Patient Data Listings, statistical reports, Clinical Study Reports.
- SAS programming and related activities for the presentation and analysis of clinical trial data.
- Contribute to review and amendment of departmental processes and supporting documentation.
- Project management activities for identified projects including financial, resource planning and utilization, timelines and milestone management.
- Provide support for special committees, e.g., DMCs, including input/review of charters and ensuring maintenance of appropriate blinding.
- Contact with client across multiple disciplines.
- Contribute to proposal activities and client presentations.
- Represent the department during audits.
- Masters or PhD in a statistical discipline.
- Previous experience of working as a Lead Biostatistician in either a biotech, CRO or pharma company.
- Interpersonal and effective communication skills, being able to explain statistical concepts to junior and non-statisticians.
- Self-motivated and ability to motivate others.
- SAS proficiency including use of a variety of statistical procedures.
- Ability to adhere to strict guidelines and codes of practice.
- A proactive approach to management of day-to-day activities and actions that may affect Covance as a business.
- 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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