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The difference is in the data.
Senior Statistical Programmer
Location
Michigan
Posted
44 days ago
Salary
0
Seniority
Senior
Job Description
Senior Statistical Programmer
MMS
• Mastery and trained on 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 trained on SDTM standards including ability to write specifications. • Advanced knowledge of ADaM standards including supporting specification writing. • Proficient with MS Office applications. • Advanced knowledge of ICH, 21CRF 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
- Masters 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 emerging leader in 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, & the drug development process.
Benefits
- Health insurance
- Retirement plans
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