Clinical StatisticionPosted: November 20, 2009
NO Corp to Corp : NO H1B
This is a full-time permanent position working at the company site.
Currently looking for: STATISTICIAN
GENERAL SUMMARY:
Manage biostatistical activities related to drug product development for assigned clinical studies. Collaborate with study teams, and internal data management and/or manage CRO data management.
DUTIES AND RESPONSIBILITIES:
Collaborate with Biostatistics, Clinical and Medical Writing on clinical trial protocols, case report forms, statistical analysis plans, and other study related activities.
Provide statistical services in drug development under supervision of statistical management Provide statistical support for submission of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies Collaborate with internal Data Management professionals, and/or manage Data Management and Biostatistical personnel at CROs Perform clinical data analyses, and work closely with statistical programmers Collaborate with development partners
REQUIREMENTS:
M.S. required in Statistics, Biostatistics, Public Health or related field; PhD recommended
3+ years experience in clinical trials including marketing applications
3+ (NDA/BLA) submissions, including FDA and other regulatory agency
3+ experience
Excellent communication and writing skills Excellent programming skills, especially in SAS. S-Plus is a plus
Experience with cancer clinical trials and/or time-to-event data preferred Knowledge of FDA, EMEA and ICH guidelines and regulations covering clinical trials, statistics, and data management Knowledge of EDC and CDISC preferred Please refer to job code DMS when responding to this ad.
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