For a confidential consultation call James Carrera on 0044 (0) 207 255 6665 or email your CV to [log in to unmask]
Ref: 195/11a
Consultant Clinical Biostatistician - Medical Affairs
12 month rolling - Excellent Rate / hour
Mainland Europe
Job Summary:
Your primary responsibility will be the overseeing trial design and reporting. Preparing statistical aspects of development plans for new drug indications with minimum review. Act as Statistics representative for cross-functional teams and management review, including Therapeutic Area management review. This will involve working closely with clinical project physicians in Corporate Medical Affairs.
Accountabilities/Responsibilities:
* Leads statistical input for at least one disease indication, including review with Therapeutic Area management.
* Advise and contribute to the methodological and statistical aspects of clinical trials and protocols
* development of statistical analysis plans;
* program and execute statistical analyses;
* write statistical reports
* Clinical study design.
* Analysis planning for clinical studies.
* Statistical input to clinical study reports.
* Provides statistical support to other disciplines related to clinical statistics.
* Serves as a primary contact with outside investigators in the preparation of scientific presentations and manuscripts.
* Represents department in meetings with regulatory agencies.
Essential Skills & Capabilities:
You are expected to have an MSc or PhD degree in statistics or mathematics. You also have a comprehensive working knowledge of biostatistical methodology based on a successful career as a statistician in international clinical drug development for several years.
Good to advanced knowledge of SAS programming and at least some other significant statistical software (e.g., S-Plus, PASS). Basic knowledge of regulatory guidance documents such as ICH guidances. Demonstrated written and oral communication skills. Demonstrated leadership skills.
All applicants must be fluent in English (verbal & written).
For further details or a confidential conversation please contact me directly:
James Carrera
Manager - Statistics, Biostatistics & Programming
Pharmaceutical, Healthcare & CRO Division
Tel: +44 (0) 207 255 6665
[log in to unmask]
http://uk.linkedin.com/in/jamescarrera
Pharmaceutical, clinical trials, statistician, statistics, statistical, SAS, programmer, programming, statistics, statistician, biostatistics, biostatistician
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