Covance

Principal Biostatistician - FSP

Company
Covance
Location
Poland
Salary
Competitive
Posted
06 Jan 2021
Closes
05 Feb 2021
Ref
10024_51800-poland
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
  • Senior Principal or Principal Biostatistician required to work for Covance on studies in Phases I and IIa/b
  • 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.

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: https://www.covance.com/services/functional-service-provision.html

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

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)

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:

FSP, Functional Service Provision, Clinical Analytics, FSPx, Adaptive Design, Umbrella, Platform, "Bayesian analysis", Principal, Statistician, Biostatistician, Stato, Statistics, Senior Biostatistician, Study Biostatistician, pharma, pharmaceutical, Bloemfontein, Vienna, Brussels, Sofia, Prague, Paris, Berlin, Athens, Budapest, Dublin, Rome, Vilnius, Amsterdam, Warsaw, Lisbon, Bucharest, Moscow, Bratislava, Madrid, Bern, Basel, Kiev, Slough, Berkshire, London, England, Edinburgh, United Kingdom, Cambridge, Swansea, Sheffield, Manchester, Alderley Edge, Birmingham, home based, field based, home-based UK Anywhere, anywhere in England, anywhere in Scotland, anywhere in Wales, anywhere in Ireland, flexible location, CDISC, SDTM ADaM, "Statistical Analysis Plan", study protocols, clinical study reports, integrated summary of safety and efficacy reports, Investigator Brochures, periodic safety update reports, oncology, rare diseases, Europe, cancer, Austria, Belgium, Bulgaria, Czech Republic, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Slovakia, Spain, Switzerland, Ukraine, South Africa,

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