Senior Principal / Principal Biostatistician - FSP

  • Covance
  • Deutschland
  • 28/09/2020
Full time Data Science Data Analytics Big Data Statistics Biostatistics

Job Description

Job Overview:
Senior Principal or Principal Biostatistician required to work for Covance on studies in Phases I and IIa/b
Split role overseeing 2 other Statisticians, being main point of contact as well as performing more hands-on work
You will be employed by Covance and work within our FSPx department 100% dedicated to one Sponsor
The Sponsor is a top 20 bio-pharmaceutical company and they have a very exciting and strong oncology pipeline
Office based in any of our European or South African offices or home based anywhere in Europe or South Africa
You must be an experienced Lead Biostatistician with strong oncology experience gained within a CRO/Pharma
Candidates must be fluent in English language (both verbal and written)
Pro-active attitude, good communication and project management skills required
Discover new opportunities to grow your career as a Covance FSP Principal Biostatistician. Covance FSP are looking to hire a Senior Principal or Principal Biostatistician with experience in Oncology. Our partner has an incredibly exciting and strong oncology pipeline with over 40 ongoing studies in Phases I and II. You will be part of a team dedicated to early phase (Phases I, IIa and IIb) Oncology projects. In this dual role the statistician will perform day to day statistics work on a study level like amending an SAP, updating TLF mock shells, reviewing ADaM data sets and TLFs, supporting the CSR etc. You will also oversee 2 other statisticians working within this FSP and provide guidance, communicate with other 3rd party vendors etc. The position offers a strong support network, flexible working solutions and the opportunity to raise your profile in the industry. If you are looking to strengthen your therapeutic expertise within oncology whilst gaining exposure to a Bio-Pharmaceutical working environment this is a fantastic opportunity.

This is an incredibly exciting time to be joining Covance as we continue to grow and expand. This is a full-time home or office-based role anywhere within Europe or South Africa.

What is FSP?
At Covance, you can redefine what is possible and discover your extraordinary potential within our Functional Service Provider team (FSP).

As a Covance employee dedicated to an FSP project you will bring your specialized discipline to a core team working directly with one sponsor. Whether your specialization is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance Covance has an FSP opportunity to match your area of expertise.

Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. We have multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house on Covance studies.

With the support of exceptional people and an energized purpose, you’ll be empowered to own your career journey with dedicated mentoring, training and personalized development planning. Further information can be found at:

Job Primary Functions
Apply knowledge of basic and complex statistical design, analysis, and programming techniques
Efficiently and effectively coordinate statistical activities for multiple projects simultaneously
Serve as primary statistical representative for biometrics standalone projects or otherwise complex studies
Participate in bids & proposal as well as marketing activities for Covance.
Effectively manage broad based projects such as NDA submissions or complex, multi-protocol programs, potentially coordinating activities across multiple locations
Develop and execute study designs and regulatory strategy as related to drug development
Maintain awareness of project budgets and tasks, and effectively communicate the status of such tasks to line management and the project manager, as appropriate
Provide guidance and work direction to more junior Biostatisticians. Actively monitor project budgets and help staff identify resource or scope of work changes.
Interact with project team and line manager to identify project priorities and communicate such activities and associated timelines to departmental management
A comprehensive full job description is available. Education/Qualifications:
Master’s degree, equivalent, or higher in Biostatistics or related field Experience:
You must be an experienced Lead Biostatistician with oncology experience gained within a CRO/Pharma
Experience with Adaptive Design trials
Experience with Umbrella/Platform trials preferred but not required
Experience with Bayesian analysis preferred
Ability to write code to validate efficacy outputs required
Excellent communications skills (written and spoken) for both internal and external communications.
Well organized and proactive
Experience with SAS statistical software
Experience with regulatory submissions and support preferred
Ability to maintain confidentiality of data and information during interactions with staff at all levels
Extensive experience in leading statistical activities in clinical research
Ability to program in one or more statistical software packages used to conduct statistical analyses
Proven ability to effectively communicate statistical concepts
Candidates must be fluent in English language (both verbal and written)


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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