Executive Director, Biostatistics

Company Overview

Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.

Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.

This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.

Tango’s labs and offices are currently located at 201 Brookline Avenue, in the vibrant Fenway neighborhood of Boston. 

Summary

Reporting to the Vice President, Biometrics, this role will serve as a strategic partner to cross-functional clinical teams, leading statistical strategy and execution across Tango’s clinical development portfolio. The position is accountable for the oversight and quality of statistical deliverables produced by external CRO partners, ensuring alignment with program objectives and regulatory expectations. This is a high-impact opportunity to contribute to the development of transformative therapies with the potential to meaningfully improve patients’ lives. The ideal candidate is a clear and influential communicator, highly collaborative, self-directed, and forward-thinking, with the ability to anticipate needs and drive outcomes in a dynamic environment.

Your Role:

• Lead the biostatistics function in developing statistical strategy, design, and analyses for conducting clinical trials for oncology in all phases
• Provide strategic input on Tango Therapeutics development programs
• Provide technical oversight of the statistical design, conduct, and analysis of clinical trials in all phases
• Contribute to clinical protocol development, including authoring or review of the Statistics section and reviewing of other sections by applying statistical principles
• Author or review the development of statistical analysis plans for clinical trials and oversee the development of tables, figures, and listings, and associated deliverables
• Develop and/or apply statistical theories, methods, and software
• Partner in clinical development program, study design, establishing standards for clinical conduct, and the collection, management and/or 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 leader and leaders in other functions
• Lead initiatives for process improvement and or standardizations for 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 team to deliver interim reports, final reports, safety updates and publications
• Guide the successful completion of major programs, projects and/or functions by identifying and implementing appropriate techniques and evaluation criteria
• Lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods, and staffing
• Management and statistical analysis of data obtained from Phase I - IV clinical studies in support of NDAs
• Interact with FDA, APAC or EU Authority staff to ensure clinical studies meet regulatory requirements
• Attend meetings with FDA, APAC or EU Authority to ensure ongoing agreement on project development
• Contribute to the development of Requests-for-Proposals for evaluation of Contract Research Organizations for biostatistics, programming, and data management activities
• Evaluate and manage contract research organizations and other vendors, including scope-of-work, timelines, deliverables, and budgets
• Responsible for statistical oversight within the biostatistics function
• Build strong relationships both within and outside biostatistics
• Project management and contract negotiation with outside vendors
• Conduct statistical modeling to enable robust and efficient statistical designs and address identified or potential statistical issues arising with studies
• Support inspection readiness activities
• Address statistical questions/comments from FDA and other regulatory agencies, or IRB/ECs
• Support and contribute to the preparation of publications, including manuscripts, posters, and oral presentations as needed

Strategic & Functional Leadership

• Lead the biostatistics function, defining statistical strategy for oncology programs across all phases of clinical development
• Provide strategic input to program teams and senior leadership on development plans and data-driven driven ‑driven decision‑making
• Develop, implement, and continuously improve departmental policies, standards, and best practices
• Develop, and mentor project statisticians; guide teams toward delivering high quality‑quality results aligned with organizational goals
• Build and maintain strong partnerships across Biometrics, Clinical Development, Regulatory, and external stakeholders

Clinical Trial Design & Methodology

• Provide expert statistical leadership on clinical study design, endpoint selection, and quantitative methods to ensure scientific rigor and regulatory compliance
• Contribute to protocol development, authoring or reviewing statistical sections, and ensuring robust trial design
• Author or review Statistical Analysis Plans (SAPs) and oversee the development of tables, figures, and listings (TFLs)
• Apply advanced statistical theories, modeling, and simulation to enable efficient and innovative trial designs
• Ensure the quality, integrity, and reproducibility of statistical methodologies across all programs

Execution, Analysis & Interpretation

• Oversee statistical conduct of Phase I–IV clinical trials, including analyses supporting NDAs and global submissions
• Direct statistical interpretation of study results and partner with cross‑functional teams to deliver interim analyses, top‑line results, safety updates, and clinical study reports
• Ensure inspection readiness and compliance with internal quality standards and regulatory expectations
• Guide the successful completion of major programs by selecting appropriate statistical techniques and evaluation criteria

Regulatory Strategy & Agency Engagement

• Provide strategic statistical and regulatory guidance to anticipate challenges and mitigate risks across development programs
• Lead statistical interactions with FDA, EMA, and APAC authorities, including preparation for and attendance at regulatory meetings
• Address statistical questions from regulatory agencies, IRBs, and Ethics Committees

Vendor & Program Oversight

• Oversee statistical deliverables generated by CRO partners, ensuring alignment with program goals, timelines, and quality expectations
• Contribute to RFP development and evaluation of CROs for biostatistics, programming, and data management
• Manage vendor scope, timelines, deliverables, budgets, and contract negotiations as needed
• Provide strong program leadership across cross‑functional teams, ensuring clarity in roles, expectations, and outcomes

Publications & Scientific Communication

• Support the development of scientific publications, including manuscripts, posters, and presentations, ensuring statistical accuracy and clarity
• Communicate statistical concepts effectively to diverse audiences, including non‑statistical stakeholders

What You Bring: 

• 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 teams that execute 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

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.