Position Summary: The Director of Biostatistics will play a critical role in the design, analysis, and interpretation of clinical trials. This individual will provide strategic leadership and expertise in biostatistics to support our Phase III clinical programs. The ideal candidate will have a strong background in biostatistics, experience in CNS clinical trials, and a passion for innovative research.
Key Responsibilities:
- Lead the biostatistics function for Phase III clinical trials, ensuring robust statistical design and analysis.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and data management, to develop and execute statistical analysis plans.
- Provide statistical input into clinical trial protocols, study design, and regulatory submissions.
- Oversee the preparation of statistical sections of clinical study reports, regulatory documents, and publications.
- Ensure compliance with regulatory guidelines and industry standards for statistical practices.
- Mentor and develop junior biostatisticians, fostering a culture of continuous learning and innovation.
- Stay current with advancements in biostatistics and clinical trial methodologies, applying best practices to our research programs.
Qualifications:
- Ph.D. or Master's degree in Biostatistics, Statistics, or a related field.
- Minimum of 10 years of experience in biostatistics, with a focus on CNS clinical trials.
- Proven track record of leading biostatistics efforts for Phase III clinical trials.
- Strong knowledge of regulatory requirements and guidelines for clinical trials.
- Excellent communication and leadership skills, with the ability to work effectively in a collaborative team environment.
- Proficiency in statistical software (e.g., SAS, R) and clinical trial data management systems.
