Job Location: Plano, TX
The Clinical Data Scientist role in Product Development will work with biostatistics, programming, medical writing, clinical development, and regulatory to assume the role of subject matter expert for clinical data and will apply this expertise broadly in support of clinical development activities.
RESPONSIBILITIES:
- Represent product development in cross functional meetings
- Provide scientific expertise to support data interpretation through collaboration with biostatistics, statistical programming, medical writing, clinical development, and regulatory
- Translate exploratory analysis requests from management to biostatistics and programming to address clinical, regulatory, or other development questions
- Contribute to briefing documents, study reports, slide presentations, regulatory interactions/response, or other documents containing written interpretation of clinical trial data
- Ensure accuracy of clinical trial results in written documents
- Identify new opportunities for clinical development through assessment of scientific, commercial, and regulatory landscape
- Assist with generation and review of abstracts, publications, regulatory documents, and presentations for scientific, regulatory, and investor activities
- Support implementation and development of predictive models related to product efficacy and clinical trial design through collaboration with biostatistics and clinical development
QUALIFICATIONS:
- Doctoral degree in biological sciences or engineering (required)
- Strong quantitative/analytical skills and a background focus in renal, neurological, cardiovascular, metabolism or immunology-related diseases (preferred)
- Excellent writing and communication skills
- Ability to work both independently and in a team setting
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