o Strong interpersonal skills and excellent written/oral communication skills.
o Demonstrated ability to collaborate with other functions, including data managers, statistical programmers, clinical scientists, project management, regulatory, and commercial staffs.
o Ability to represent statistics on internal teams, including senior level decision committees, and in interactions with contract research organizations, external advisors and regulatory agencies.
o Ability to communicate, influence, and lead in a large complex matrix organization. Ability to self directed and organize workload, prioritize, complete tasks on time, and manage activities of the supporting functions
o Demonstrated ability to assume a leadership role, especially in championing innovative statistical designs on a cross-functional team
o Ability to identify and solve technical problems, and when necessary, provide and input on innovative study designs, such as Bayesian/adaptive designs.
Specialised Knowledge:
breadth & depth across disciplines or functions; expertise in field required; separate by basic and preferred
o Statistical consulting experience with non-statisticians
o Ability to review / co author protocols, clinical study reports, and integrated summaries. Ability to author reporting & analysis plans. Ability to provide comprehensible and defensible statistical interpretations with release of headline results, statistical analysis package (SAC). Ability to perform exploratory analyses.
o Track record of statistical contributions and accomplishments in clinical development as a matrix representative for statistics. Experience with the design, analysis and reporting of clinical studies, as well as contributions to the overall clinical development plan. Experience with regulatory agencies is a plus
o SAS programming skill is a must
Basic Requirements:
M.S. in Bio/Statistics with at least 3 years of industry experience with a multinational pharma or biotech company, or
Ph.D. in Bio/Statistics with, preferably, 2+ years of industry experience with a multinational pharma or biotech company
Preferred Requirements:
Thesis dissertation or working knowledge of innovative statistical methods, e.g. Bayesian methodology, adaptive design, and dose finding modeling.
Industry experience in preclinical and early phase clinical trials (i.e. FTiH to PoC)
Knowledge with neurology therapeutic areas
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发表于 2014-5-9 14:21:56