Covance Job - 32151694 | CareerArc
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Company: Covance
Location: Rome, Lazio, Italy
Career Level: Mid-Senior Level
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job Overview:

  • Senior Biostatistician required to work for Covance leading 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 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 Senior Biostatistician.  Covance FSP are looking to hire a Senior 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

  • Perform Lead Biostatistician role on medium complexity studies, providing statistical oversight and attending relevant project meetings
  • Perform project management activities for identified projects including resource planning, timelines and milestone management
  • Preparation of Statistical Analysis Plans (including mock TFL shells) for medium complexity studies under the supervision of more senior statistical staff
  • 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
  • May perform sample size calculation for simple studies under the supervision of more senior statistical staff
  • Develop the statistical sections of the protocol for simple to medium complexity studies under the supervision of a statistical consultant
  • Provide statistical input and review of the CSR for medium complexity studies
  • Preparation and review of randomization specifications and generation of randomization schedules
  • Mentor of biostatisticians within project activities; assigned tasks related to the development of staff within the department
  • Present and share knowledge at team meetings and/or at monthly seminars
  • Attend bid defense meetings for medium complexity studies in order to win new business
  • Represent the department during project-driven client audits.

A comprehensive full job description is available.

Education/Qualifications:
  • Master's degree, equivalent, or higher in Biostatistics or related field
Experience:
  • You must have previous Lead experience working as an experienced 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
  • Ability to effectively communicate statistical concepts
  • A good knowledge of the overall clinical trial process
  • Experience in the preparation of Statistical Analysis Plans, analysis, reporting, etc
  • 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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