Director Of Biostatistics

Position Overview: We are looking for a seasoned professional to join our team as the Director of Biostatistics. Reporting directly to the Chief Scientific Officer, the Director of Biostatistics will play a critical role in shaping the direction of our clinical development programs. This individual will lead a team of statisticians and collaborate closely with cross-functional teams to design, analyze, and interpret clinical trials data, ensuring the highest standards of statistical rigor and accuracy.

Key Responsibilities:

• Leadership: Provide strategic direction and leadership to the biostatistics team, fostering a culture of excellence, collaboration, and innovation.
• Statistical Design: Lead the statistical design of clinical trials, including sample size determination, randomization schemes, and statistical analysis plans.
• Data Analysis: Oversee the analysis of clinical trial data, ensuring adherence to protocol and regulatory guidelines, and providing statistical insights to support decision-making.
• Interpretation and Reporting: Interpret study results and communicate findings effectively to internal stakeholders, regulatory agencies, and external partners through statistical reports and presentations.
• Regulatory Compliance: Ensure compliance with regulatory requirements and industry standards for statistical analysis and reporting, including FDA and EMA guidelines.
• Cross-functional Collaboration: Collaborate closely with clinical development, regulatory affairs, medical affairs, and other functional areas to integrate statistical considerations into overall development strategies.
• Methodological Innovation: Stay abreast of advancements in statistical methodologies and apply innovative approaches to address complex scientific challenges.
• Mentorship and Development: Provide mentorship, coaching, and professional development opportunities to the biostatistics team members, fostering their growth and career advancement.



Qualifications:

• Ph.D. or Master's degree in biostatistics, statistics, or a related field.
• 8+ years of experience in biostatistics within the pharmaceutical or biotechnology industry.
• Proven track record of leading statistical efforts for clinical development programs from Phase I through Phase III.
• Strong knowledge of statistical methodologies, study design, and regulatory requirements for clinical trials.
• Proficiency in statistical software such as SAS, R, or Python.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Prior experience managing and developing a team of statisticians is highly desirable.
• Demonstrated ability to thrive in a fast-paced, dynamic environment and manage multiple priorities effectively.