For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]
Ref: 054/11a
Contract: Principal / Trial Biostatistician, Biostatistics
Excellent Rate / hour
Mainland Europe
Job Summary:
Perform duties of a Trial Statistician to support complex clinical trials within national or international development projects or for marketed products as required. Collaborate with members of Clinical Research and Marketing, Trial Clinical Monitor and trial teams incl. pharmacokineticist in planning clinical trials and protocols conforming to company and regulatory agency guidelines and/or marketing and publication strategies.
Accountabilities/Responsibilities:
Act as Project Statistician for early projects, backup projects, or projects with established BI experience.
Support Project Statisticians of high profile international projects in their responsibilities, especially in their statistical responsibilities in the planning and preparation of regulatory submissions and contribute to efforts on cross-trial planning and harmonization.
Analyze data from phase I to IV trials incl. responsibility for program validation. Perform exploratory analyses in collaboration with the Project Statistician.
Prepare accurate, high quality reports of complex clinical trials for registration of drugs and biologics, publications and management.
Prepare specifications for data analyses by outside vendors as required. Assure compliance with the specifications by reviewing the vendors' products.
Participate on assigned international teams to promote harmonization efforts for clinical drug development.
Support management in resource planning and tracking for assigned trials and projects.
Essential Skills & Capabilities:
* M.Sc in statistics, biostatistics, or biometry; with at least 6 years experience in pharmaceutical clinical trial experience, preferably in the pharmaceutical industry and/or Regulatory Authorities.
* Ability to interact with authorities on statistical issues at the trial level.
* Thorough knowledge of statistical methodology, processing clinical trial information and the drug development process.
* Ability to communicate statistical information to non-statisticians.
* Ability to write publications (as joint author) in clinical trials.
* Excellent oral and written communication skills.
* Ability to manage project from a statistical perspective.
* Demonstrated ability to design, conduct and analyse a complex trial
For further details or a confidential conversation please contact me directly:
James Carrera
Manager - Pharmaceutical, Healthcare & CRO Division
Statistics, Biostatistics & Programming
Tel: +44 (0) 207 255 6665
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http://uk.linkedin.com/in/jamescarrera
Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician
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