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I am looking for applicants for the following role - 

Associate Director of Statistics - Hampshire, UK

PRINCIPAL RESPONSIBILITIES include: 
  
·   Providing leadership in biometrics activities pertaining to study   
projects. 
·   Providing input into development of the CDP and individual study 
design. 
·   Providing the specification and reviews of draft randomisation 
schedules. 
·   Reviewing and approving the SAP.
·   Providing the statistical analyses and reviewing statistical outputs. 
·   Reviewing the statistical methodology sections(s) of study reports for 
study and integrated summary reports. Consulting with the Medical Writer 
and Physician on the interpretation of efficacy results. 
·   Reviewing CRFs, abstracts, posters, and manuscripts to support Medical 
Affairs.
·   Identifying the need for contractors and supervising contractors to 
support projects. 
·   Participating in providing statistical training to Global Biometrics 
and other Research and Development staff. Providing input as required to 
the VP of Global Biometrics on SOPs in order to meet current regulatory 
needs.
·   Following all relevant SOPs and working practices. 
·   Contributing to the establishment and maintenance of common formats 
and templates for key Biometrics documentation (eg statistical section of 
protocol, standard CRF pages, Statistical Analysis Plans, Tables, Figures 
and Listings). 
·   Contributing to the design of standards for SAPs.
·   Some international travel required. Domestic travel on project needs 
basis.
·   Supporting Global Medical Affairs through consultation and review of 
abstracts, manuscripts and posters.
·   Providing strategic and tactical input in the contracting with Global 
Biometrics preferred providers.

QUALIFICATIONS, KNOWLEDGE & EXPERIENCE:

·   MS in Biostatistics or closely related field is required. PhD in 
Biostatistics or closely related field is strongly preferred.
·   Strong background and working knowledge of statistical methods that 
apply to all phases of clinical trials. 
·   Must have a working knowledge of statistical analysis plans including 
the report outline, mockup tables, graphs and data listing shells and 
appendices. 
·   Must have a working knowledge of all appropriate relevant regulatory 
guidances (e.g. ICH, FDA and EMEA). 

SKILLS & PERSONAL ATTRIBUTES:

·   Strong attention to detail and accuracy. 
·   Ability to read, analyse and interpret complex technical documents. 
·   Ability to communicate complex issues in oral and written form.
·   Must be able to work in a fast paced environment with demonstrated 
ability to prioritise multiple competing tasks and demands.  
·   Ability to respond to regulator`s inquiries for products undergoing 
registration and approved products. 


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