Careers
Job Description Exposure to clinical trials from Phase I to Phase IV in a multitude of therapeutic areas are essentials. You must possess consultative skills: ability to uncover client needs and an ability to communicate complex details in a concise manner. Responsibilities: - Protocol Development - Clinical Study Design - Writing ICH Reports - Medical Writing and Manuscript preparation - Development of statistical analysis plans - Consulting in Bio-statistics, study design and regulatory issues - Interviewing and selecting new Statisticians and SAS Programmers / Statisticians - Serve as a resource to other statisticians in the department - Periodic review of STAT SOPs Requirements: - Ph.D. in Statistics/Biostatistics - 5 years experience in clinical drug development (CRO exposure an asset) in: - Protocol and Clinical Study design - Clinical data management - SAS programming - Clinical research report writing - Exposure to many therapeutic areas including Cardiovascular, Oncology, Endocrinology and CNS - Experience in the analysis and reporting of Phase I-IV clinical trials - Advanced communication skills written and oral - Excellent interpersonal skills - Flexible and comfortable with tight and changing timelines - Knowledgeable with ICH, FDA, EMEA and TPD guidelines and regulatory issues Back to Careers |
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