Senior Principal Biostatistician

Bad Homburg vor der Höhe, , Germany
Salary
Competitive
Start date
16 Aug 2020
Closing date
24 Aug 2020
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Discipline
,
Hours
Contract Type
Experience Level
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Job Details

Job Overview:

• Experienced Senior Principal Biostatistician r equired to work for Covance
• Working with multiple Sponsors across several therapeutic areas in all phases of clinical trials (mainly PII & PIII)
• 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 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 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 expertise within a varied and dynamic environment, then this is a fantastic opportunity.

Job Primary Functions

• Lead complex studies such as NDA submission or complex, multi-protocol programs, potentially coordinating activities across multiple locations, providing statistical oversight and attending relevant project meetings
• Perform project management activities for identified projects including resource planning, timelines and milestone management
• Serve as DMC Support Statistician, developing DMC Charters and attending DMC Meetings
• Lead the development of complex Statistical Analysis Plans, perform senior review of statistical analysis plans developed by other statisticians
• Perform complex statistical analyses, quality check statistical analyses developed by other statisticians
• Conduct overall statistical review of TFLs for complex studies prior to client delivery
• Review CRF and other study specific specifications and plans
• Perform complex sample size calculations
• Develop the statistical sections of the protocol for complex studies under the supervision of a statistical consultant/Statistical Fellows
• Provide statistical input and review of the CSR for complex studies
• Preparation and review of randomization specifications and generation of randomization schedules
• Provide mentoring and training to less experienced staff; provide direction and review work of departmental employees to ensure accuracy and adherence to pertinent departmental policies, practices, and procedures
• Present and share knowledge at monthly seminars and /or team meetings and at external scientific meetings and conferences
• Attend bid defense meetings for complex studies such as NDA submissions or complex, multi-protocol programs in order to win new business
• Act as Subject Matter Expert and develop or review procedural documents, or work on new initiatives
• Represent the department during audits

Education/Qualifications:

• Master's degree, equivalent, or higher in Biostatistics or related field

Experience:

• Previous experience of working as a Principal Biostatistician in either a biotech, CRO or pharma company
• Ability to program in one or more statistical software packages (SAS®) used to conduct statistical analyses. SAS proficiency including use of a variety of statistical procedures e.g., non-parametric analysis, linear and non-linear models, categorical data and survival analysis
• Proven ability to effectively communicate statistical concepts
• 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 Cooperative, team-oriented and proactive
• Self-motivation
• The ability to work to tight deadlines while maintaining high standards
• Ability to adhere to strict guidelines and codes of practice
• Ability to explain statistical concepts to non-statisticians
• Coordination 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
• Ability to motivate others
• 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.

Keywords:

Senior Principal Biostatistician, Senior Principal Statistician, Principal Biostatistician Principal Statistician, Senior Biostatistician, Statistician, Medical Statistician, Clinical Statistician, Covance, Chiltern, Phases II-IV, Lead Statistician, Lead Biostatistician, SAP, Statistical Analysis Plans, pharma, pharmaceutical, SAS, home based, office based, office-based, home-based, flexible working, flexible location, home based UK Anywhere, anywhere in United Kingdom, UK, Great Britain, England, London, Maidenhead, Reading, Edinburgh, Scotland, Swansea, Wales, Northern Ireland, Ireland, Maidenhead, Berkshire, Edinburgh, France, Paris, Spain, Madrid, Barcelona, Germany, Munich, Berlin, Frankfurt, Cologne, Poland, Russia, Ukraine, Italy, Rome, Milan, Warsaw, Moscow, St Petersburg, Saint Petersburg, Smolensk, Kiev, Kyiv

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

Company info

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Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom
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