Formation Bio

Formation Bio

Senior Director, Biostatistics

Boston, MA; New York, NY · Director

Sponsorship not specified$311k-$389kDetected 22 days ago
RGCPMachine LearningSparkData ScienceStatisticsBusiness DevelopmentFDA RegulatorySASResearchExperimental DesignLeadershipCommunicationCollaborationProblem SolvingMentoringBiostatistics

About the role

  • About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development.
  • The company is backed by investors across pharma and tech, including a16z, Sequoia, Sanofi, Thrive Capital, John Doerr, Spark Capital, SV Angel Growth, and others.
  • About the Position Formation Bio is seeking a highly skilled and experienced Senior Director, Biostatistics to join our dynamic team.

Responsibilities

  • 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.
  • 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.
  • 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.

Requirements

  • 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.

Nice to have

  • 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.

Compensation

  • Individual compensation is determined by several factors, including role scope, geographic location, and skills & experience.
  • Your offer will reflect where you fall within the range based on these considerations.
  • In addition to base salary, we offer equity, comprehensive benefits, and generous perks.
  • If the posted range doesn't match your expectations, we still encourage you to apply!
  • Where We Hire Formation Bio is prioritizing hiring in key hubs, primarily the New York City and Boston metro areas, with a hybrid model requiring 3 days per week in office.
  • Applicants from the Research Triangle (NC) and San Francisco Bay Area may also be considered.

Benefits

  • Our Vision for AI in Pharma
  • Strong understanding of regulatory guidelines for drug development, including FDA and EMA requirements for statistical practice, regulatory submissions, and health authority interactions.

Company info

  • Advancements in AI and drug discovery are creating more candidate drugs than the industry can progress because of the high cost and time of clinical trials.
  • Recognizing that this development bottleneck may ultimately limit the number of new medicines that can reach patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate all aspects of drug development and clinical trials.

Equal opportunity

  • Formation Bio is committed to building a diverse and inclusive team.
  • We are an equal opportunity employer and welcome candidates from all backgrounds.
  • All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, ancestry, sex (including pregnancy, childbirth, breastfeeding, and related medical conditions), gender identity or expression, sexual orientation, age, disability, genetic information, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.
  • Equal Opportunity Formation Bio is committed to building a diverse and inclusive team.
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