| Skill |
statistics, biostatistician, biostatistics, SAS, S-Plus, drug development, Masters Degree, PhD, |
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 (NDA/BLA) submissions, including FDA and other regulatory agency experience
Excellent communication and writing skills
Excellent programming skills, especially in SAS. S-Plus is REQUIRED
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 |