Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to lead and develop the biostatistics team and strategy, driving impactful statistical initiatives to advance drug development processes.
In Short
Lead and develop the Biostatistics team.
Drive statistical strategy across clinical development programs.
Provide expert statistical input into clinical study design.
Collaborate with cross-functional teams for regulatory strategies.
Establish and refine statistical workflows and best practices.
Champion data-driven decision-making frameworks.
Engage with external scientific discussions and collaborations.
Oversee statistical vendors and ensure compliance with standards.
Stay updated on industry trends and regulatory expectations.
Foster a high-performance culture within the team.
Requirements
Ph.D. in Biostatistics or related field with 10+ years of experience.
Proven experience leading biostatistics teams.
Expertise in statistical trial designs and adaptive designs.
Strong understanding of regulatory guidelines.
Experience in quantitative decision-making frameworks.
Ability to collaborate cross-functionally.
Strong problem-solving skills.
Excellent communication skills.
Proficiency in SAS, R, and statistical software.
Passion for innovation and data-driven methodologies.