BioSpace
Senior Director of Biostatistics | BioSpace
About Formation Bio
Formation Bio is a tech‑driven, AI‑powered pharmaceutical company that accelerates drug development by improving clinical trial efficiency and increasing the probability of success. Founded in 2016 (formerly TrialSpark Inc.), we build technology platforms, processes, and capabilities that partner, acquire, or in‑license drugs from pharma companies, research organizations, and biotechs to advance programs past clinical proof of concept. Our investors include a16z, Sequoia, Sanofi, Thrive Capital, and others.
About The Position Formation Bio seeks a Senior Director of Biostatistics to lead and develop the biostatistics team and strategy. Reporting to the Head of Biometrics, this role will shape innovative trial designs, support regulatory strategies, and ensure high‑quality statistical contributions across clinical development while integrating advanced analytics and AI into our programmes.
Responsibilities
Lead & develop the Biostatistics team, fostering a high‑performance culture aligned with Formation Bio’s mission and values. Provide mentorship and career development.
Drive statistical strategy across clinical development, incorporating optimal trial designs, simulation‑based approaches, and AI/ML applications. Guide clinical and regulatory strategies to optimize trial design and maximize success probability.
Provide expert statistical input into study design, endpoint selection, analysis planning, and regulatory interactions. Explore innovative trial designs to align with business needs and regulatory expectations.
Partner with Clinical, Data Science, Regulatory, and Business Development teams to support drug diligence, development, regulatory interactions, briefing books, and submission activities. Represent Biostatistics in key regulatory meetings (e.g., FDA, EMA).
Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards.
Champion data‑driven approaches and quantitative decision‑making frameworks, integrating scenario analyses and trial simulations to optimise execution and strategic development plans.
Stay at the forefront of industry trends and regulatory expectations and represent Formation Bio in scientific discussions, conferences, and collaborations.
Oversee and manage statistical vendors, including consulting statisticians and CROs, ensuring high‑quality deliverables and compliance with GCP and regulatory standards.
About You
Ph.D. in Biostatistics, Statistics, or related field with 10+ years of experience in biostatistics within pharma/biotech, consulting firms, or CROs supporting clinical development.
Proven experience leading biostatistics teams and strategies within clinical development.
Deep expertise in trial designs, adaptive designs, Bayesian methods, and simulation‑based approaches for early and late‑stage development.
Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice and regulatory submissions.
Experience in quantitative decision‑making frameworks to support internal Go/No‑Go decisions.
Track record of leading statistical contributions from diligence through regulatory approval.
Excellent cross‑functional collaboration skills with Clinical, Data Management, Programming, Data Science, Regulatory, and other teams.
Strong problem‑solving skills with the ability to balance scientific rigor and operational efficiency.
Excellent communication skills, translating complex statistical concepts into actionable insights for non‑statisticians and senior management.
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.
Location Priority hiring centers: New York City, Boston metro areas, Research Triangle (NC), and San Francisco Bay Area. Applicants must reside in one of these locations or be willing to relocate.
Only apply if you meet these location requirements.
Compensation Target salary range: $262,000 – $340,000 (base salary only). In addition to base salary, Formation Bio offers equity, comprehensive benefits, generous perks, hybrid flexibility, and more.
Equal Opportunity Statement You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Job Details
Seniority level: Director
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industries: Internet News (Note: Alignment data may vary; for this role only)
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About The Position Formation Bio seeks a Senior Director of Biostatistics to lead and develop the biostatistics team and strategy. Reporting to the Head of Biometrics, this role will shape innovative trial designs, support regulatory strategies, and ensure high‑quality statistical contributions across clinical development while integrating advanced analytics and AI into our programmes.
Responsibilities
Lead & develop the Biostatistics team, fostering a high‑performance culture aligned with Formation Bio’s mission and values. Provide mentorship and career development.
Drive statistical strategy across clinical development, incorporating optimal trial designs, simulation‑based approaches, and AI/ML applications. Guide clinical and regulatory strategies to optimize trial design and maximize success probability.
Provide expert statistical input into study design, endpoint selection, analysis planning, and regulatory interactions. Explore innovative trial designs to align with business needs and regulatory expectations.
Partner with Clinical, Data Science, Regulatory, and Business Development teams to support drug diligence, development, regulatory interactions, briefing books, and submission activities. Represent Biostatistics in key regulatory meetings (e.g., FDA, EMA).
Establish and refine statistical workflows, SOPs, and best practices to improve efficiency, quality control, and compliance with industry standards.
Champion data‑driven approaches and quantitative decision‑making frameworks, integrating scenario analyses and trial simulations to optimise execution and strategic development plans.
Stay at the forefront of industry trends and regulatory expectations and represent Formation Bio in scientific discussions, conferences, and collaborations.
Oversee and manage statistical vendors, including consulting statisticians and CROs, ensuring high‑quality deliverables and compliance with GCP and regulatory standards.
About You
Ph.D. in Biostatistics, Statistics, or related field with 10+ years of experience in biostatistics within pharma/biotech, consulting firms, or CROs supporting clinical development.
Proven experience leading biostatistics teams and strategies within clinical development.
Deep expertise in trial designs, adaptive designs, Bayesian methods, and simulation‑based approaches for early and late‑stage development.
Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice and regulatory submissions.
Experience in quantitative decision‑making frameworks to support internal Go/No‑Go decisions.
Track record of leading statistical contributions from diligence through regulatory approval.
Excellent cross‑functional collaboration skills with Clinical, Data Management, Programming, Data Science, Regulatory, and other teams.
Strong problem‑solving skills with the ability to balance scientific rigor and operational efficiency.
Excellent communication skills, translating complex statistical concepts into actionable insights for non‑statisticians and senior management.
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.
Location Priority hiring centers: New York City, Boston metro areas, Research Triangle (NC), and San Francisco Bay Area. Applicants must reside in one of these locations or be willing to relocate.
Only apply if you meet these location requirements.
Compensation Target salary range: $262,000 – $340,000 (base salary only). In addition to base salary, Formation Bio offers equity, comprehensive benefits, generous perks, hybrid flexibility, and more.
Equal Opportunity Statement You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Job Details
Seniority level: Director
Employment type: Full‑time
Job function: Research, Analyst, and Information Technology
Industries: Internet News (Note: Alignment data may vary; for this role only)
#J-18808-Ljbffr