Senior Director of Biostatistics

As a Senior Director of Biostatistics at Formation Bio, your primary responsibilities will include leading the biostatistics team, driving statistical strategy across clinical development programs, and providing expert statistical input for clinical study design and execution. You will also collaborate with various departments to enhance resource allocation through AI-driven clinical trial automation while representing biostatistics in key regulatory meetings.

To qualify for the Senior Director of Biostatistics position at Formation Bio, candidates should possess a Ph.D. in Biostatistics or a related field along with at least 10 years of experience in the pharmaceutical or biotech industry. Expertise in statistical trial designs, thorough knowledge of regulatory guidelines, and leadership experience in biostatistics teams are essential.

Formation Bio leverages AI to enhance statistical strategies and optimize clinical trial designs. As a Senior Director of Biostatistics, you will incorporate AI/ML applications into the statistical approach, thereby improving efficiency and maximizing success probability in clinical development.

The salary range for the Senior Director of Biostatistics role at Formation Bio varies based on location, with the target range for candidates in the NYC and Boston areas being $275,000 - $340,000, while remote candidates may expect a range of $262,000 - $323,000. This package also includes equity and comprehensive benefits.

Yes, remote work is an option for the Senior Director of Biostatistics position at Formation Bio; however, candidates based outside of the NYC Metro Area are expected to travel to the office for key meetings at least four times a year to maintain collaboration and connection within the team.

In your answer, showcase examples of your leadership style, such as how you've mentored team members, fostered collaboration, and enhanced performance through effective strategies. Mention specific instances where your leadership contributed to successful project outcomes.

Discuss various statistical methods, emphasizing your familiarity with trial designs, adaptive methods, and Bayesian techniques. Provide examples of how you've applied these methods in past projects to optimize study outcomes.

Your response should outline your understanding of regulatory guidelines for drug development. Discuss how you prepare statistical evidence for regulatory submissions and your experiences with agencies such as the FDA or EMA.

Share a specific example involving a data-related challenge. Highlight your analytical skills and problem-solving techniques, demonstrating how you collaborated with cross-functional teams to devise a solution.

Indicate your commitment to professional development through attending conferences, participating in webinars, or being part of industry groups. Share examples of how this knowledge has informed your work.

Discuss your experiences with AI applications in biostatistics, highlighting any tools or methodologies you're familiar with. Emphasize how you've utilized AI to improve efficiency and decision-making processes.

Explain your experience in creating and adhering to SOPs (Standard Operating Procedures) and quality control measures. Detail how you educate your team on best practices for compliance and quality assurance.

Provide a specific example where you utilized quantitative analysis to influence a significant decision in clinical development. Emphasize the impact of this approach on project outcomes.

Discuss your mentoring philosophy and methods, such as conducting regular one-on-one meetings, providing feedback on projects, or organizing workshops to enhance their development and skills.

Share details about your experience overseeing statistical vendors and CROs, emphasizing your strategies for ensuring high-quality deliverables and compliance with regulatory standards throughout collaborations.