Executive Director, Biostatistics

Role Summary

Reporting to the Vice President, Biometrics, this role serves as a strategic partner to cross-functional clinical teams, leading statistical strategy and execution across Tango’s clinical development portfolio. It oversees statistical deliverables produced by external CRO partners to ensure alignment with program objectives and regulatory expectations. This is a high-impact role focused on advancing transformative cancer therapies, requiring a clear communicator who is collaborative, self-directed, and forward-thinking.

Responsibilities

• Lead the biostatistics function, defining statistical strategy for oncology programs across all phases of clinical development.
• Provide strategic input on Tango development programs.
• Oversee the statistical design, conduct, and analysis of clinical trials in all phases.
• Contribute to clinical protocol development, including authoring or reviewing the Statistics section.
• Author or review SAPs and oversee the development of tables, figures, and listings.
• Develop and apply statistical theories, methods, and software.
• Partner in clinical development program design, establishing standards for clinical conduct, and the collection, management and reporting of data.
• Recruit, develop, and supervise project statisticians.
• Apply sound statistical methodology to meet project objectives, health authority guidelines, and regulatory requirements.
• Develop and implement biostatistics department policies, standards, practices, and work instructions in coordination with senior department leaders.
• Lead initiatives for process improvement and standardization of biostatistics activities and deliverables.
• Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success.
• Review protocols and case report forms for soundness of trial design.
• Review statistical analysis plans for all phases of a trial.
• Direct analysis, interpret study results, and collaborate with study teams to deliver interim reports, final reports, safety updates and publications.
• Guide the successful completion of major programs by identifying and implementing appropriate techniques and evaluation criteria.
• Lead or manage the work of others by providing guidance to subordinates or teams, with responsibility for results, costs, methods, and staffing.
• Management and statistical analysis of data obtained from Phase I–IV clinical studies in support of NDAs.
• Interact with FDA, EMA, or APAC/EU Authority staff to ensure clinical studies meet regulatory requirements; attend regulatory meetings as needed.
• Contribute to the development of RFPs for evaluating CROs for biostatistics, programming, and data management activities.
• Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables, and budgets.
• Responsible for statistical oversight within the biostatistics function.
• Build strong relationships within and outside biostatistics; collaborate across cross-functional teams.
• Project management and contract negotiation with outside vendors.
• Conduct statistical modeling to enable robust and efficient design, and address identified or potential statistical issues arising with studies.
• Support inspection readiness activities.
• Address statistical questions or comments from FDA and other regulatory agencies, or IRBs/ECs.
• Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations as needed.
• Build and maintain partnerships across Biometrics, Clinical Development, Regulatory, and external stakeholders.

Qualifications

• Advanced degree (MS/MA or PhD) in Statistics, Biostatistics, or a related quantitative field, with extensive industry experience demonstrating progressive leadership and impact. Typically, 12+ years of relevant experience with an MS/MA or 10+ years with a PhD, or an equivalent combination of education and deep oncology experience.
• At least 10 years of experience in oncology clinical trials, with demonstrated leadership of Phase 1–4 programs (Phase 3 experience strongly preferred).
• Proven experience supervising and developing multiple statisticians, including guiding day-to-day operational and CRO oversight responsibilities.
• Expert knowledge of regulatory guidelines (FDA, EMA, ICH) and statistical/clinical considerations for drug development.
• Hands-on experience supporting major regulatory submissions, including INDs, NDAs, and/or MAAs.
• In-depth expertise with CDISC standards (SDTM, ADaM) and their application to oncology studies.
• Strong command of statistical principles, experimental design, and analytical methods, particularly in the context of oncology trials.
• Proficiency using modern statistical software and tools, such as SAS, R, and EAST, for design and analysis.
• Ability to manage multiple studies and compounds simultaneously, delivering high-quality work under tight timelines in a dynamic environment.
• Excellent people-management and interpersonal skills, with a track record of developing talent and building strong cross-functional relationships.
• Exceptional communication skills, including the ability to convey complex statistical concepts to diverse audiences.
• Strong conflict-management and problem-solving capabilities, with the judgment to navigate ambiguity and make sound decisions.
• Broad understanding of adjacent disciplines, including clinical development, clinical operations, clinical science, data management, regulatory affairs, and drug safety.