Senior Director Biostatistics - AI/ML
We have a current opportunity for a Senior Director Biostatistics - AI/ML on a permanent basis. The position will be based in New York. For further information about this position please apply.
We're seeking an accomplished and visionary Senior Director, Biostatistics to join our dynamic and fast‑growing organization. Reporting to the Head of Biometrics, this leader will oversee the development and execution of our biostatistical strategy, elevate the capabilities of the Biostatistics function, and drive statistical innovation across clinical development programs. The ideal candidate is an influential strategic thinker who brings scientific rigor, operational excellence, and a passion for leveraging modern analytics, advanced methodologies, and AI‑driven solutions to accelerate drug development and increase probability of success.
Key Responsibilities
Strategic Leadership
- Lead, develop, and inspire the Biostatistics team, cultivating a high‑performance, collaborative, and innovation‑driven culture that aligns with Formation Bio's mission and values.
- Provide mentorship, coaching, and career development to strengthen technical excellence and scientific leadership across the group.
Statistical Strategy & Innovation
- Define and drive biostatistical strategy across all clinical development programs, integrating optimal trial designs, simulation‑based methods, and AI/ML technologies to improve efficiency and decision‑making.
- Partner with cross‑functional stakeholders to shape clinical and regulatory strategies, optimizing designs to maximize program success and accelerate development timelines.
Study Design & Execution
- Provide expert statistical leadership for clinical study designs, including endpoint selection, estimands, SAP development, and statistical modeling approaches.
- Evaluate and propose innovative design options (adaptive, Bayesian, or AI‑assisted) to ensure scientific rigor, operational feasibility, and alignment with regulatory expectations.
- Use AI‑enabled clinical trial automation tools to streamline execution, enhance resource utilization, and improve trial efficiency.
Regulatory & Cross‑Functional Collaboration
- Act as the primary biostatistics representative in interactions with regulatory agencies (e.g., FDA, EMA), contributing to briefing books, meeting preparation, and submission‑related documentation.
- Collaborate closely with Clinical Development, Data Science, Regulatory, and Business Development on asset diligence, study planning, and integrated evidence generation strategies.
Operational Excellence
- Establish and refine statistical workflows, SOPs, QC standards, and best practices that enhance efficiency, accuracy, and compliance with industry regulations and internal governance.
- Drive continuous improvement initiatives that elevate the quality and scalability of Biostatistics operations.
Data‑Driven Decision‑Making
- Promote quantitative decision‑making frameworks across programs, leveraging simulation, statistical modeling, and scenario planning to inform key clinical and portfolio decisions.
External Engagement
- Represent Formation Bio in scientific forums, publications, partnerships, and conferences to maintain visibility, stay informed on trends, and contribute to the broader biostatistics community.
Vendor & CRO Management
- Oversee statistical vendors, CROs, and external consultants to ensure high‑quality deliverables, alignment with expectations, and compliance with GCP and regulatory standards.
About You
- Ph.D. in Biostatistics, Statistics, or a related discipline with 10+ years of biostatistics experience in pharmaceutical, biotech, CRO, or consulting environments supporting clinical development.
- Must have technical data science experience utilizing AI/ML with clinical biostatistics
- Demonstrated success leading biostatistics teams and strategy within complex clinical development settings.
- Deep expertise in innovative trial methodologies, including adaptive designs, Bayesian approaches, simulation-based design, and modern statistical frameworks across early‑ and late‑stage programs.
- Strong working knowledge of FDA/EMA statistical guidelines, regulatory pathways, and health authority interactions.
- Experience applying quantitative decision‑making frameworks to inform Go/No‑Go decisions and strategic program advancement.
- Proven record of driving statistical contributions from diligence through regulatory submissions and approvals.
- Highly collaborative, with the ability to partner effectively across Clinical, Data Management, Programming, Data Science, Regulatory, and BD.
- Strong problem‑solving capabilities with a balanced approach to scientific rigor and operational practicality.
- Excellent communication skills, able to translate complex statistical concepts into clear, actionable insights for diverse audiences, including executives and regulators.
- Proficiency in SAS and R, with familiarity in tools for sample‑size estimation (e.g., EAST, PASS, nQuery); advanced R programming preferred.
- Passion for innovation, AI‑driven methodologies, and data‑centric approaches that transform clinical development.
Salary: $290-380,000 base salary + additional benefits
FAQs
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