Employer Industry: Pharmaceutical Research and Development

Why consider this job opportunity:
- This position is eligible for 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 innovative projects that impact health solutions and clinical trials.
- Collaborate with cross-functional teams and contribute to industry standards development.

What to Expect (Job Responsibilities):
- Actively participate in defining standards for SDTM mapping, data collection, and data review rules.
- Ensure consistency across 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 and other documentation for regulatory submissions.
- Represent the employer's interests in industry standards development projects and identify process improvements.

What is Required (Qualifications):
- Experience leading the development of standards for data collection, tabulation, analysis, and/or reporting.
- Experience with SDTM and CDASH.
- MS with 6 years or BS with 8 years of relevant clinical research experience.
- Active participation in CDISC teams is preferred.
- Experience preparing SDTM and/or ADaM datasets for regulatory submissions.

How to Stand Out (Preferred Qualifications):
- Experience with standards related to eye care, neuroscience, or medical aesthetics.
- Familiarity with standards related to devices.
- Knowledge of ADaM, Analysis Results Metadata, or TLF standards.

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