We are seeking a highly skilled and experienced Director of Biostatistics to join an innovative CNS focused Pharma. This role involves overseeing the design, analysis, and interpretation of complex clinical and preclinical data to support our research and development efforts. The ideal candidate will possess a strong background in biostatistics, excellent leadership abilities, and a deep understanding of clinical trial methodologies.
Key Responsibilities:
- Leadership & Management: Lead and mentor a team of biostatisticians, providing guidance on statistical methods, data analysis, and study design.
- Study Design: Collaborate with cross-functional teams to design statistical methodologies for clinical trials and research studies, ensuring robust and scientifically sound approaches.
- Data Analysis: Oversee the analysis of clinical trial data, including interim and final analyses, and provide clear and actionable insights to support decision-making.
- Regulatory Compliance: Ensure that statistical practices comply with regulatory guidelines and industry standards. Prepare and review statistical sections of regulatory submissions.
- Collaboration: Work closely with clinical, regulatory, and data management teams to ensure seamless integration of statistical analysis with overall project goals.
- Strategic Input: Contribute to the strategic planning of research programs, providing expert statistical advice to shape the direction of clinical and preclinical development.
- Innovation: Stay abreast of advances in statistical methodologies and software, and apply innovative techniques to enhance the quality and efficiency of data analysis.
Qualifications:
- Education: Advanced degree (Ph.D. or Master's) in Biostatistics, Statistics, or a related field.
- Experience: Minimum of 8 years of experience in biostatistics, with at least 3 years in a leadership or managerial role within the pharmaceutical or biotechnology industry.
- Technical Skills: Expertise in statistical software (e.g., SAS, R) and a strong understanding of clinical trial design and analysis.
- Regulatory Knowledge: Familiarity with regulatory requirements and guidelines for clinical trials.
- Communication: Excellent verbal and written communication skills, with the ability to convey complex statistical concepts to non-statistical stakeholders.
