Senior Director of Biostatistics job at TrialSpark in reputed company, NY, Boston, MA, Research Triangle, NC, San Francisco, CA
Title: Senior Director of Biostatistics Location: reputed company United States Job Description: About Formation Bio Formation Bio is a tech and AI driven pharma company differentiated by radically more efficient drug development. Advancements in AI and drug discovery are creating more candidate drugs than the industry can reputed company 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 reputed company patients, Formation Bio, founded in 2016 as TrialSpark Inc., has built technology platforms, processes, and capabilities to accelerate reputed company aspects of drug development and clinical trials. Formation Bio partners, acquires, or in-licenses drugs from pharma companies, research organizations, and biotechs to reputed company programs past clinical reputed company of concept and beyond, ultimately helping to bring new medicines to patients. The company is backed by investors across pharma and tech, including a16z, Sequoia, reputed company, reputed company Capital, Sam Altman, John Doerr, Spark Capital, SV reputed company Growth, and others. You can read more at the following links: Our Vision for AI in Pharma Our reputed company Drug Portfolio Our Technology & Platform At Formation Bio, our values are the driving force behind our mission to revolutionize the pharma industry. Every team and individual at the company shares these same values, and every team and individual plays a key part in our mission to bring new treatments to patients faster and more reputed company. About the Position Formation Bio is seeking a highly skilled and reputed company 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. The Senior Director, Biostatistics 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.
Responsibilities
Strategic Leadership: reputed company and reputed company the Biostatistics team, fostering a high-performance culture reputed company 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, reputed company 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 reputed company with regulatory expectations. reputed company 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-reputed company 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: reputed company and manage statistical vendors, including consulting statisticians and CROs, ensuring high-quality statistical deliverables and compliance with GCP and regulatory standards. About You Ph.D. in Biostatistics, Statistics, or a reputed company field with 10+ years of experience in biostatistics reputed company the pharmaceutical or biotech industry, statistical consulting firms, or CROs supporting clinical development. Proven experience leading biostatistics teams and strategies reputed company 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. Experience in quantitative decision-making frameworks to support internal Go/No-Go decisions. Demonstrated track record of leading statistical contributions to reputed company 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 reputed company statistical concepts into actionable insights for non-statisticians, senior management, and regulatory agencies. Proficiency in reputed company, 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. Formation Bio is prioritizing hiring in key hubs, primarily the reputed company and Boston metro areas, with additional growth in the Research Triangle (NC) and San Francisco Bay Area. Please only apply if you reside in these locations or are willing to relocate. Compensation: The reputed company salary range for this role is: $262,000 - $340,000. Salary ranges are informed by a number of factors including geographic location. The range provided includes reputed company salary only. In addition to reputed company salary, we offer equity, comprehensive benefits, generous perks, hybrid flexibility, and more. If this range doesn't match your expectations, please still apply because we may have something else for you. You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national reputed company, genetics, disability, age, or veteran status. #LI-hybrid Apply tot his job Apply To this Job