Job Overview :
Experienced Senior Principal Biostatistician required to work within Covance’s Statistical Analysis Research Centre
You will Lead in the design and consult on complex studies and multi-protocol programs as well as Leading the DMC process
Previous experience of supporting data monitoring committees essential
This is a permanent full-time role, either office based, or home based anywhere in Europe
Join our growing team and discover your extraordinary potential by working as a Covance Senior Principal Biostatistician within our SARC (Statistical Analysis Research Centre) team.
The SARC team is a service group within Covance that can provide statistical expertise, statistical consulting, or independent statistical review for clinical protocol design to regulatory submissions.
Within the SARC team, we have very talented set of individuals with many years of statistical and pharmaceutical expertise in all phases of clinical development and several therapeutic areas.
Job Primary Functions
Lead in the design and consult on complex studies and multi-protocol programs. Providing statistical oversight and attending relevant project meetings
Lead the DMC process and management and serve as DMC Support Statistician as project manager including the development of DMC Charters, attending DMC Meetings, and writing DMC Meeting minutes
Perform project management activities for identified projects including resource planning, timelines and milestone management
Lead the development of complex Statistical Analysis Plans. Perform senior review of statistical analysis plans developed by other statisticians.
Provide statistical support as a consultant for complex study designs as required
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
Perform sample size calculations
Develop the statistical sections of the protocol for complex studies. Provide input as necessary as a Statistical Consultant
Provide statistic input and review of the CSR for complex studies
Preparation and review of randomization specifications and generation of randomization schedule
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
Education / Qualifications :
Master’s degree, equivalent, or higher in Biostatistics or related field
Demonstrate good knowledge in supporting data monitoring committees with excellent organizational skills, communication skills and writing skills
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
Full knowledge of the interactions required by a biostatistician throughout the lifespan of a trial; a good knowledge of the responsibilities of those departments with whom biostatisticians and statistical programmers interact
Strong supervisory skills, and ability to organize their own and others' work
Excellent problem solving skills, and a willingness to take ownership of decision-making
Interpersonal and effective communication skills; able to communicate appropriately throughout Covance and with its clients
A substantial knowledge of the overall clinical trial process
A broad up-to-date knowledge of statistics as applied in clinical trials across therapeutic areas and to complex statistical methods (including adaptive design and platform trial design)
Demonstrates good knowledge of clinical research guidance, including Food and Drug Administration (FDA), international regulatory agencies, international conference on harmonization (ICH), and good clinical practice (GCP).
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.
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