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Senior Statistical ProgrammerJob Specific Skills: Mastery and training in generating tables, listings, and graphs from clinical trial databases using SAS.Utilizes System Development Life Cycle (SDLC) for programming deliverables.Advanced user in SAS programming, SAS Base, and SAS Macros.Advanced knowledge of E-Submission Standards, Guidelines, and Regulations.Mastery and training on SDTM standards including the ability to write specifications.Advanced knowledge of ADaM standards including supporting specification writing.Proficient with MS Office applications.Advanced knowledge of ICH, 21 CFR Part 11, and ISO 9001:2000 requirements.Advanced experience with pooling of data sets for submissions.Advanced experience with BIMO outputs, define.xml, Reviewer's Guides, SDSP.Lead study or small programming project teams.Job Requirements: Master's degree required for all Statistics roles.Minimum of 5 years' experience in Statistical Programming or similar field required.Expert knowledge of scientific principles and concepts.Reputation as an emerging leader in the field with sustained performance and accomplishment.Proficiency with MS Office applications.Hands-on experience with clinical trial and pharmaceutical development preferred.Good communication skills and willingness to work with others to clearly understand needs and solve problems.Excellent problem-solving skills.Good organizational and communication skills.Familiarity with current ISO 9001 and ISO 27001 standards preferred.Familiarity with 21 CFR Part 11, FDA, and GCP requirements.Basic understanding of CROs and scientific & clinical data/terminology, and the drug development process.Should you not have received a response within 14 days of your application, please consider your application unsuccessful.
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