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Senior Analyst, Data Standards (Remote)
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Job Description
- Req#: 3743990007750604
Employer Industry: Pharmaceutical and Biotechnology
Why Consider this Job Opportunity:
- Salary range is competitive, with the possibility of participation in short-term incentive programs
- Comprehensive benefits package including paid time off, medical, dental, vision insurance, and 401(k)
- Opportunity for remote work from anywhere in the U.S.
- Engage in meaningful work that contributes to innovative medicines and solutions
- Collaborate with a cross-functional team and participate in industry standards development
What to Expect (Job Responsibilities):
- Contribute to the development of data and reporting standards for clinical trials, focusing on CDASH and SDTM standards
- Actively participate in defining standards for SDTM mapping, data collection, and review rules
- Educate the organization on the proper use of data standards in pipeline activities
- Review and provide feedback on SDTM Mapping Specifications and Trial Design Domains
- Consult on conformance issues for SDTM and/or ADaM, working with study teams to resolve problems
What is Required (Qualifications):
- MS with 6 years of relevant clinical research experience, or BS with 8 years of relevant clinical research experience
- Experience leading the development of standards for data collection, tabulation, analysis, and/or reporting
- Proficiency with SDTM and CDASH
- Experience preparing SDTM and/or ADaM datasets and documentation for regulatory submissions
- Familiarity with industry standards and regulatory requirements related to CDISC
How to Stand Out (Preferred Qualifications):
- Active participation in CDISC teams
- Experience with standards related to eye care, neuroscience, or medical aesthetics
- Knowledge of standards related to devices
- Experience with ADaM, Analysis Results Metadata, or TLF standards
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