g********l
发帖数: 26 | 1 Got the below job information from a friend. The job is from GSK China based
in Shanghai (Zhangjiang). If you are interested in it, please send your
resume and CV to a**********[email protected].
thanks!
sam
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JOB FACTORS
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Job Purpose and Key Responsibilities:
This individual will be a member of SPDM team to provide pivotal statistical
input into all phases of the neuroscience pipelines, with a
focus on the discovery projects. Key responsibilities include
a. Preclinical statistical consulting and data analysis, i.e. assisting
the design and analyses for the animal in vivo experiments
design,
b. Contributing/leading the design, analysis and reporting FTiH to PoC
clinical trials
c. Supporting later phase clinical development programs aiming for both
global and regional (China) regulatory filing
Accountability:
Review/co-author protocols, study design, analysis and reporting plans,
statistics analysis, study reports, integrated summaries,
publications, presentations, and regulatory documents. Derives statistical
conclusions and makes recommendations based on study results.
Works with business partners to understand and help define requirements.
Represents statistics on internal team meetings, contract
organizations, investigator and advisory board meetings, and meetings with
external regulatory agencies.
Complexity:
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.
Specialized Knowledge:
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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