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http://biotech.fyicenter.com/jobs/99896065_Associate_Director_Biostatistics.html
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Date: 16-Aug-2007
Associate Director, Biostatistics y
Key Responsibilities
Provides leader****p in biometrics activities pertaining to study
projects. Provides input into development of the CDP and individual
study design. Provides specification and reviews draft randomization
schedules. Reviews and approves the SAP. Provides the statistical
analyses. Reviews statistical outputs. Reviews the statistical
methodology sections(s) of study re****ts for study and integrated
summary re****ts. Consults with the Medical Writer and Physician on the
interpretation of efficacy results. Reviews CRFs. Reviews abstracts,
posters, and manuscripts to sup****t Medical Affairs.
Key Skills and Competencies
Provides input as required to the VP of Global Biometrics on SOPs in
order to meet current regulatory needs. Follows all relevant SOPs and
working practices. Contributes to the establishment and maintenance of
common formats and templates for key Biometrics do***entation (eg
statistical section of protocol, standard CRF pages, Statistical
Analysis Plans, Tables, Figures and Listings). Contributes to the
design of standards for SAPs.
Educational & Experience Requirements
* M.S. in Biostatistics or closely related field is required. * Ph.D.
in Biostatistics or closely related field is strongly preferred. *
Significant and relevant pharmaceutical development experience and
competency.
* 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 re****t 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). * Strong attention to detail and accuracy. *
Ability to read, analyze and interpret complex technical do***ents. *
Ability to communicate complex issues in oral and written form. *
Ability to establish priorities and meet deadlines. * Must be able to
work in a fast paced environment with demonstrated ability to
prioritize multiple competing tasks and demands. * Ability to work
independently, take initiative and complete tasks to deadlines with
quality. * Demonstrated ability to work in a team environment. *
Ability to communicate effectively upwards, downwards, and laterally
throughout the organization.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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