Senior Director of Biostatistics, Formation Bio
$311-388.5k
Offers equity
3+ days a week in office
Powering hyper-efficient, tech-driven drug development
Job no longer available
Powering hyper-efficient, tech-driven drug development
101-200 employees
Job no longer available
$311-388.5k
Offers equity
3+ days a week in office
101-200 employees
Company mission
To bring new treatments to patients faster and more efficiently.
Role
Who you are
- Experience in quantitative decision-making frameworks to support internal Go/No-Go decisions
- Demonstrated track record of leading statistical contributions to progress assets from diligence, early development through regulatory submissions and approvals
- Ability to collaborate cross-functionally with Clinical, Data Management, Programming, Data Science, Regulatory, and other teams
- Strong problem-solving skills with the ability to balance scientific rigor with operational efficiency
- Excellent communication skills, with the ability to convey complex statistical concepts into actionable insights for non-statisticians, senior management, and regulatory agencies
- Proficiency in SAS, R (S-Plus), and statistical software for sample size calculations (e.g., East, PASS, NQuery). Expert R programming skills are a plus
- Passion for innovation, AI-driven methodologies, and data-driven decision-making in clinical development
Desirable
- Ph.D. in Biostatistics, Statistics, or a related field with 10+ years of experience in biostatistics within the pharmaceutical or biotech industry, statistical consulting firms, or CROs supporting clinical development
- Proven experience leading biostatistics teams and strategies within clinical development
- Deep expertise in statistical trial designs, adaptive designs, Bayesian methods, and simulation-based approaches for both early and late-stage development
- Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice, regulatory submissions, and health authority interactions
What the job involves
- Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team. This critical role will report to the Head of Biometrics and will be responsible for leading and developing the biostatistics team and strategy, driving impactful statistical initiatives, and leveraging biostatistics to advance our drug development processes
- This person will play a key role in shaping innovative trial designs, supporting regulatory strategies, and ensuring high-quality statistical contributions across clinical development. They will also collaborate cross-functionally to integrate advanced analytics, data-driven decision-making, and AI applications into our development programs to improve efficiency and increase the probability of success
- Strategic Leadership: Lead and develop the Biostatistics team, fostering a high-performance culture aligned with Formation Bio’s mission and values. Provide mentorship and career development to ensure team growth and expertise
- Statistical Strategy & Innovation: Drive statistical strategy across clinical development programs, incorporating optimal trial designs, simulation-based approaches, and AI/ML applications to enhance efficiency and decision-making. Guide clinical and regulatory strategies to optimize trial design and maximize the probability of success
- Study Design & Execution: Provide expert statistical input into clinical study design, endpoint selection, analysis planning, and regulatory interactions. Explore innovative trial design options to identify the most effective clinical development strategy that aligns with business needs and optimizes decision-making. Ensure study designs are scientifically rigorous, operationally feasible, and aligned with regulatory expectations. Leverage AI-driven clinical trial automation to enhance study execution, optimize resource allocation, and improve trial efficiency
- Regulatory & Cross-Functional Collaboration: Partner with Clinical, Data Science, Regulatory, and Business Development teams to support drug diligence, development and regulatory interactions, FDA briefing books, and submission-related activities. Represent Biostatistics in key regulatory meetings (e.g., FDA, EMA) to ensure statistical rigor in clinical development plans
- Operational Excellence: Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards
- Data-Driven Decision-Making: Champion data-driven approaches and quantitative decision-making frameworks, integrating scenario analyses and statistical trial simulations to optimize clinical trial execution and strategic development plans
- External Engagement: Stay at the forefront of industry trends and regulatory expectations, representing Formation Bio in scientific discussions, conferences, and collaborations
- Vendor & CRO Management: Oversee and manage statistical vendors, including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards
Our take
Clinical drug trials are lengthy and expensive, delaying the supply of vital new drugs to patients and costing lives. For Formation Bio, this is an efficiency issue - one which it hopes to solve with its end-to-end automation solution.
According to the company, its approach has teams running medical trials twice as fast and at half the cost. This success has pushed Formation to expand beyond supporting trials into developing assets itself. In 2025, it reached a major milestone by licensing its first drug in a deal worth up to hundreds of millions. Alongside this, the company has also added an early immunology program to its pipeline, signalling a broader push into in-house development.
Now a Unicorn, with partners including Pfizer, Sanofi, Novartis and 23andMe, Formation Bio is steadily embedding itself within the Big Pharma ecosystem. How far it can go remains an open question, but the prospect of cheaper drugs and faster innovation is becoming harder for the industry to ignore.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
30% employee growth in 12 months
Company
Funding (last 2 of 3 rounds)
Jun 2024
$372m
SERIES D
Sep 2021
$156m
SERIES C
Total funding: $530.3m
Company benefits
- Flexible Time Off: We have a flexible PTO policy and we encourage our team members to take the time that they need to recharge
- Parental Leave: All parents receive 12 weeks of fully paid bonding leave to welcome a newborn, adopted, or fostered child, and birthing parents are eligible for an additional 6-8 weeks of paid leave
- Comprehensive Benefits: All full time employees have access to health, vision, and dental insurance. Additionally, we provide pre-tax commuter benefits, access to a 401k plan, short and long-term disability and life insurance.
- Education & Career Development Resources: Formation Bio offers a plethora of professional development resources to employees, including a yearly L&D stipend, internal mobility opportunities, in depth trainings, leadership coaching, and more.
- Community: Our teams collaborate closely to achieve our mission, supporting each other across functions and priorities. We build connection through team-building events, quarterly company gatherings, a biennial company-wide retreat, and various Employee Resource Groups.
Company values
- Think in first principles: We rigorously interrogate all possible paths to understand how we can do things differently and faster. We challenge assumptions, ask why, and solve problems from the ground up
- Be a scientist: We are curious and we continuously learn. We steelman, not strawman in debates. We listen, rapidly iterate, and make the best decisions with the evidence we have
- Deliver care: We lead with empathy. We value different perspectives, collaborate across teams, and support one another. We give and receive direct, actionable and timely feedback to hold ourselves and others to a high bar
- Champion the mission: We keep the mission as our north star and deliver impact for patients. We hold ourselves accountable for our wins and failures and keep moving forward
Company HQ
Midtown South, New York, NY
Articles
Leadership
Benjamine Liu
(Co-Founder & CEO)Worked as a computational biologist at various Neurology departments, following a D.Phil in computational Biology and Psychiatry at Oxford. They are also an Advisor at Harvard Business School.
Linhao Zhang
(Co-Founder)Linhao is also the Founder of Foundation 649. Previously, they were a Product Engineer at Oscar Insurance, a Software Engineer at Salesforce, and co-founder of Day 7 Photography.
Dan Neil
(CTO)Prior to joining Formation Bio in 2025, Dan was the Chief Data Officer at Tessera Therapeutics. Before that, they spent nearly 7 years at BenevolentAI in various roles, including SVP of AI & NY Site Lead and CTO.
Dale Klasko
(Senior Vice President, People)Dale built her career as a campus recruiting leader and strategic people business partner at growth-stage companies in the adtech & finservices industries.
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