Principal Biostatistician Consultant at ClinChoice overseeing drug development statistical methodologies. Lead statistician for clinical studies in a hybrid work environment.
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Hybrid Manager, Clinical Scientist – Internal Medicine, Cardio, Metabolic, Renal
Posted 2 months ago
About the role
- Manager overseeing clinical studies in Internal Medicine, collaborating with cross-functional teams at Regeneron. Involves ensuring scientific integrity and execution of clinical studies.
Responsibilities
- Assists in the development, evaluation, planning and execution of clinical studies
- Ensures scientific integrity and interpretation of study data of a clinical development program
- Contributes to candidate development projects through early and/or late phase development
- Collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies
- Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines
- Supports clinical/medical data review, including safety monitoring and activities that ensure patient safety
Requirements
- BS/MS/PhD/PharmD in a related area
- ≥ 6 years of pharmaceutical clinical drug development experience
- Experience in one or more of the following therapeutic areas is preferred – cardiovascular, renal, metabolic disease
- Basic knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines
Benefits
- health and wellness programs (including medical, dental, vision, life, and disability insurance)
- fitness centers
- 401(k) company match
- family support benefits
- equity awards
- annual bonuses
- paid time off
- paid leaves (e.g., military and parental leave)
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