Our client company is a global biotechnology firm; they are driven by a
desire to attain scientific excellence in order to achieve new standards of
care. They currently have over twenty products in clinical development
addressing a variety of key medical needs. They operate in over 70 countries
and have over 3,000 employees worldwide.
Our client is now looking for an ambitious and determined individual to take
on the position of Director of Biostatistics within their research and
development team in Massachusetts, US. This position is for someone who
wants to take the next step within their career development and to do it
within a forward thinking and dynamic company. This role will offer the
individual an exciting and rewarding career and the chance to be a part of a
leading team of experts within the biostatistical field.
This individual will provide strategic direction for biostatistics for one
or more therapeutic area, and direction on clinical development plans,
protocols and analysis. They will review clinical study reports and
regulatory submission materials and ensure that standard procedures are
followed within projects. As well as to provide mentorship to
biostatisticians in the department.
They will be responsible for implementing consistent statistical conduct for
the department in all locations and maintain liaison with clinical research
personnel in order to identify and meet their needs for statistical support.
They will have to interact with the head of statistical programming and data
management to synchronize prioritization of projects and represent
Biostatistics in meetings with executive committee, commercial, regulatory
agencies, and external development partners. As well as to provide guidance
to the department towards achieving departmental and corporate visions and
goals.
The candidate must have a:
- PhD in Biostatistics/Statistics or equivalent with 8 - 10 years
experience.
- At least 4 years experience in leading a team.
- Past frequent interaction with FDA.
- BLA/NDA experience essential.
- Interaction with EMEA/CPMP and preparation of an MAA an advantage.
- PhD in Biostatistics/Statistics or equivalent
If you feel as if you have the sufficient experience and qualifications to
take on this exciting role, within a forward thinking and dynamic company
then please send us a copy of your most recent CV to [log in to unmask]
<mailto:[log in to unmask]> quoting the reference number
NEC.0001.BIO.AC.
Abbi Cohen | Project Co-ordinator | AspirionPharma
Direct Line + 44 (0) 208 304 6538
Fax + 44 (0) 208 304 6549
<mailto:[log in to unmask]> abbi
<mailto:[log in to unmask]> @aspirionpharma.com
AspirionPharma is part of the Aspirion Group of Companies
<http://www.aspiriongroup.com> www.aspiriongroup.com
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