As a senior member of the ECD Biostatistics group, you will oversee a range
of projects in one or more disease areas.
You will
• work closely with a team of experts from Research, Development,
Regulatory Affairs and Marketing to provide statistical expertise for early
Clinical Development Plans,
• contribute to strategic discussions and decisions on the project
level,
• represent Biostatistics in the early International Clinical Team,
• and work with other statisticians to give guidance and expertise on
the design, analysis and reporting of clinical trials.
You continuously strive for innovative solutions for our projects and
studies, and you will develop and implement novel statistical procedures in
design or analysis. You will work with our Modeling and Simulation group to
explore data for product profiling, hypothesis generation, new research
topics and publications. For this you will have access to an international
team of internal and external statistical methodology consultants. In
addition, you will interact with health authorities, external experts and
opinion leaders to support and defend project plans and data analyses and
their interpretation. You will also oversee the preparation of regulatory
documents, like INDs.
Your qualifications:
• University degree in Statistics or Mathematics (Ph.D. or MSc. level)
• At least seven years relevant experience in the field of clinical
trials (for Ph.D. 4 years) are a must
• Good knowledge of clinical trials methodology and proven knowledge
of drug development process and Health Authority guidelines and regulations
• Basic knowledge of pharmacological/physiological sciences and PK/PD
would be a plus
• Good knowledge of scientific computation and SAS, S-Plus are an
advantage.
• Flexible, positive, creative thinker, good communicator, negotiator
and team player
• Good leadership skills and project management skills are required.
Natalie Fforde
Managing Director
Fforde
Curtis House
34 Third Ave
Hove
BN3 2PD
Tel: 01273 722366
Fax: 01273 325350
Mobile: 07769 700 222
Email: [log in to unmask]
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