via Indeed
$200K - 300K a year
Lead biostatistics, data management, and statistical programming across oncology clinical development, ensuring regulatory compliance and operational excellence.
Requires 15+ years in biostatistics within biotech/pharma, deep oncology expertise, leadership experience at senior levels, and strong regulatory knowledge.
Description: About BBOT BBOT is a clinical-stage biopharmaceutical company advancing a next-generation pipeline of novel small molecule therapeutics targeting RAS and PI3K malignancies. BBOT has the goal of improving outcomes for patients with cancers driven by the two most prevalent oncogenes in human tumors. For more information visit BBOTx.com Who You Are We are seeking an experienced and strategic leader to serve as Executive Director / Vice President of Biostatistics & Data Sciences. This individual will provide end-to-end leadership for biostatistics, data management, and statistical programming across our oncology development portfolio, spanning early development through registrational studies and lifecycle management, and will be responsible for championing new initiatives in biostatistics and other data-related disciplines. The successful candidate will be a hands-on scientific leader and trusted strategic partner to Clinical Development, Regulatory, Medical Affairs, and Commercial teams, with deep expertise in oncology trial design, regulatory interactions, and execution excellence. This role will be critical in shaping development strategy, ensuring data integrity, and enabling high-quality, efficient decision-making. Responsibilities Strategic & Scientific Leadership • Lead the biostatistics, data management, and statistical programming functions across all clinical programs. Embrace critical thinking to challenge conventions, design biostatistics work processes to drive operational excellence, and create innovative workflow to consistently escalate biostatistics team’s performance. • Serve as a core member of the clinical development leadership team, contributing to portfolio strategy, asset prioritization, and program governance. Leverage in-depth statistics knowledge and expertise to integrate with other areas across functions including clinical sciences, development operations, and digital solutions etc, to build strong in-house biometrics capabilities. • Provide statistical leadership for oncology trial design, including adaptive designs, Bayesian approaches, biomarker-driven studies, and complex endpoints (e.g., OS, PFS, ORR, MRD). Lead and participate in clinical development activities, such as clinical protocol development, study conduct, data management, statistical analysis plan, etc. • Guide development strategies from first-in-human through registrational and post-marketing studies. Apply broad and comprehensive understanding of different biostatistics methods, systems, theories, and practices, and effectively deploy effective methods pivoting to the changing business environment and driving business results. Regulatory & External Engagement • Act as the statistical authority in interactions with global regulatory agencies (FDA, EMA, PMDA, etc.), including End-of-Phase, Pre-NDA/BLA, and Advisory Committee meetings. • Oversee the statistical and data components of INDs, NDAs, BLAs, MAAs, and responses to regulatory questions. • Ensure alignment with regulatory expectations for data standards (CDISC), submission quality, and inspection readiness. Operational Excellence • Ensure timely, high-quality delivery of statistical analyses, datasets, TFLs, and clinical study reports. • Oversee CRO and vendor strategy for data management and programming, including governance, performance metrics, and cost efficiency. Provide strategic and dynamic management to establish, implement, and continuously optimize operation models to synergize sponsor – CRO collaborations. • Establish scalable processes, standards, and infrastructure to support a growing oncology pipeline. • Drive innovation in data review, analytics, and visualization to enable real-time decision-making. Apply advanced quantitative risk-benefit evaluations to provide strategic statistical guidance for decision makings in complex and fast-changing environment. People & Organizational Leadership • Build, mentor, and retain a high-performing, multidisciplinary team across biostatistics, data management, and statistical programming. • Foster a culture of scientific rigor, collaboration, accountability, and continuous improvement. • Develop succession plans and ensure the organization is positioned to support long-term growth. Cross-Functional Collaboration • Partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Medicine, Medical Affairs, and Commercial teams. • Provide statistical input into go/no-go decisions, portfolio reviews, and external communications (e.g., publications, conferences, investor disclosures). • Support medical and scientific communications, including abstracts, manuscripts, and congress presentations. Requirements: Education • PhD (preferred) or MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline. Experience • 15+ years (with PhD) or 18+ years (with MS) of experience in biostatistics within biotech or pharmaceutical development, with significant oncology experience. • Prior experience leading biostatistics and/or data sciences functions at the Senior Director, Executive Director, or VP level. • Demonstrated success supporting late-stage and registrational oncology trials and regulatory submissions. • Strong track record of managing CROs and external partners. Technical & Scientific Expertise • Deep knowledge of oncology clinical development, endpoints, and regulatory expectations. • Working knowledge of relevant FDA, EU, ICH guidelines and regulations. • Expertise in statistical methodologies for complex and innovative trial designs. • Excellent strategic thinking on innovative statistical methods and the linkage to business values. • Working knowledge of data management and statistical programming best practices, including CDISC standards. • Familiarity with modern data platforms, analytics tools, and data visualization approaches. Leadership & Communication • Proven ability to influence at the executive level and communicate complex statistical concepts to non-statistical audiences. • Outstanding communication skills (verbal and written). • Collaborative leadership style with strong decision-making and prioritization skills. • Experience managing multiple projects and operating effectively in fast-paced, resource-constrained biotech environments. Compensation BBOT considers a variety of factors when determining base compensation, including experience, skills, education, qualifications, and geographic location. Actual compensation will vary, and it is not typical to be hired at or near the top of the range for the role. Base compensation is part of a robust total rewards offering at BBOT. Additional total rewards elements include annual bonus, stock-based long-term incentives, medical, dental, and vision benefits, retirement, wellness stipend, and flexible time off.
This job posting was last updated on 2/16/2026