Employer Industry: Pharmaceutical Research and Development

Why consider this job opportunity:
- Remote work opportunity available from anywhere in the U.S.
- Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k)
- Eligible for participation in short-term incentive programs
- Opportunity to contribute to innovative medicines and solutions that address serious health issues
- Engage with a cross-functional team of experts and influence industry standards

What to Expect (Job Responsibilities):
- Participate in the development of data and reporting standards within assigned therapeutic areas
- Create and review SDTM Mapping Specifications and Trial Design Domains
- Provide feedback on CRF design and SDTM datasets to ensure compliance with regulatory requirements
- Oversee the creation of SDTM define.xml, annotated CRF, and Clinical Study Data Reviewer’s Guides for submissions
- Stay current with industry standards and identify improvements to processes and content

What is Required (Qualifications):
- Experience leading the development of standards for data collection, tabulation, analysis, and/or reporting
- Proficient in 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):
- Familiarity with standards related to eye care, neuroscience, or medical aesthetics
- Experience with standards related to devices
- Knowledge of ADaM, Analysis Results Metadata, or TLF standards

#PharmaceuticalResearch #ClinicalTrials #DataStandards #RemoteWork #HealthcareInnovation

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