Principal Biostatistician Consultant at ClinChoice overseeing drug development statistical methodologies. Lead statistician for clinical studies in a hybrid work environment.
About the role
- Clinical Scientist assisting the Clinical Research Director in studies related to asthma and inflammatory diseases. Supporting clinical trial execution and document preparation at a biopharma company.
Responsibilities
- Assist/support the Clinical Research Director (CRD) in the medical/scientific contribution for the clinical studies
- Contributes to preparation and/or review of any documents related to the studies and requiring a scientific background
- Supports Clinical Research Director in the preparation of medical answers to questions from Health Authorities, IRB/Ethics Committees, investigators, experts involved in the study/project
- Contributes to the definition of the critical data/processes/predefined deviations list, risks and Quality tolerance limits identification and monitoring
- Develop high-quality management practices and guidelines for medical data review activities using a data-driven and risk-based approach
- Support CRD in implementing, managing, organizing, and conducting Steering committees, Data Monitoring Committees, Adjudication Committee meetings
Requirements
- Advanced degree preferred (PharmD or PhD scientist or Biomedical Science master with previous experience in Clinical Research and/or Clinical Drug Development)
- 5+ years of industry experience (clinical development)
- Experience with supporting preparation and execution of clinical trials.
- Experience with basic statistical principles and techniques of data analysis, interpretation and clinical relevance.
- Experience in successful collaboration with cross-functional global teams of interdisciplinary professionals.
- Ability to interact and effectively communicate with all levels of personnel within the organization and with clients of the Sponsor company (i.e., investigators, vendors and CROs).
- Experience with interaction with regulatory Authorities for clinical trials is a plus.
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
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