IrvineFull TimeEngineering
Remotely
clinical programmingsasregulatory filingscdiscadamsas macrostlf
Job Description
📋 Description
- Leads statistical programming for a compound/indication or therapeutic area in early development.
- Manages a team of statistical programmers and resource planning.
- Ensures timely deliverables and adherence to quality processes.
- Develops SAS programs for ADaM data sets per CDISC, Tables, Listings, and Figures.
- Ensures ADaM data set consistency across studies and integrated data.
- Creates docs for regulatory filings and reviewers guides.
🎯 Requirements
- Bachelors in Statistics or Mathematics
- 10+ years relevant experience (or 8+ with a Masters)
- Experience leading a team/project of statistical programmers
- Proficient in SAS programming for drug development
- Strong understanding of CDISC standards
- ADaM development and TLF generation experience required
🎁 Benefits
- Comprehensive benefits package including PTO and medical/dental/vision
- 401(k) plan for eligible employees
- Eligibility to participate in long-term incentive programs
- AbbVie is an equal opportunity employer
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