Allergan Aesthetics
Senior Analyst, Data Standards (Remote)
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Job Description
- Req#: R00128804
Employer Industry: Pharmaceutical and Biotechnology
Why Consider this Job Opportunity:
- Opportunity for career advancement and growth within the organization
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
- Eligible to participate in short-term incentive programs
- Remote work opportunity, allowing flexibility in your work environment
- Engage in meaningful work that contributes to innovative medicines and solutions for serious health issues
What to Expect (Job Responsibilities):
- Actively participate with a cross-functional team to define standards such as SDTM mapping, data collection, and data review rules
- Ensure consistency across various standard types and educate the organization on their proper use
- Create, review, and provide feedback on SDTM Mapping Specifications and Trial Design Domains
- Oversee the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides for regulatory submissions
- Stay current with industry standards, identify improvements to processes, and drive those improvements to completion
What is Required (Qualifications):
- Experience leading development of standards for data collection, tabulation, analysis, or reporting
- Experience with SDTM and CDASH
- MS with 6 years or BS with 8 years of relevant clinical research experience
- Experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
- Active participation in CDISC teams preferred
How to Stand Out (Preferred Qualifications):
- Experience with standards related to eye care, neuroscience, or medical aesthetics
- Experience with standards related to devices
- Experience with ADaM, Analysis Results Metadata, or TLF standards
#Pharmaceutical #ClinicalResearch #RemoteWork #CareerGrowth #DataStandards
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