What are the responsibilities and job description for the Director Biostatistics position at The Lotus Group LLC?
We are seeking an experienced Director of Biostatistics to provide statistical leadership in clinical trial design, data analysis, and regulatory submissions. This role involves collaborating with cross-functional teams to support clinical development strategies and oversee outsourced biostatistics activities.
Key Responsibilities :
- Design scientifically sound clinical trials, including selection of study populations, sample sizes, and endpoints.
- Develop and review study protocols, statistical analysis plans, clinical study reports, and regulatory documents.
- Oversee biostatistical activities outsourced to CROs and external vendors.
- Collaborate with Clinical Research, Drug Safety, Regulatory Affairs, and Clinical Operations to ensure timely data analysis and reporting.
- Present statistical analyses and summary data to internal and external stakeholders.
- Support regulatory interactions, publications, and external communications.
- Manage multiple studies to ensure consistency and adherence to industry standards.
- Ensure compliance with internal processes and regulatory requirements.
Qualifications :
Seniority level
Director
Employment type
Full-time
Job function
Management, Analyst, and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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