Description:
Seeking a Senior Statistical Programmer Analyst for a successful
Biotech company in the San Francisco area. You will be part of a team
doing the preparation of data, data documentation, computer programs,
report documents, and case report forms for electronic submission of
clinical studies to the FDA. You will participle in the preparation of
materials for electronic submission to the FDA, including data, data
documentation, computer programs, reports and CRFs. Provide
consistency across protocols on format of electronic data, programs,
reports and CRFs. Work collaboratively with members of the clinical
project team to proactively define deliverables, formats, and
processes for electronic submissions.
Requirements:
Minimum of 4 years SAS programming with a BS in statistics, math,
computer science, or 2 years experience with an MS in Statistics.
Experience in SAS programming, cross-platform and cross-architecture
approaches. MS-Word, Excel, Adobe/Acrobat. Familiar with database
theory, concepts and Oracle Clinical. Thorough understanding of the
drug approval process with extensive experiences in the support of at
least one phase of drug development. Good interpersonal, written and
verbal communication skills required. Ability to communicate
effectively with biostatisticians. Knowledge in data warehousing,
database design and implementation. Understanding of regulatory
guidelines for electronic submissions.
Email resume for immediate consideration. For more information please
contact:
Tom Whiting
Enterprise Resource Group
San Francisco, CA
(voice) (415) 221-6300
(email) [EMAIL PROTECTED]
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