Executive Director – Biostatistics, Data Sciences

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🕒 February 25

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• lead the biostatistics, data management, and statistical programming functions across all clinical programs • serve as a core member of the clinical development leadership team, contributing to portfolio strategy, asset prioritization, and program governance • provide statistical leadership for oncology trial design, including adaptive designs, Bayesian approaches, biomarker-driven studies, and complex endpoints (e.g., OS, PFS, ORR, MRD) • guide development strategies from first-in-human through registrational and post-marketing studies • act as the statistical authority in interactions with global regulatory agencies (FDA, EMA, PMDA, etc.) • oversee the statistical and data components of INDs, NDAs, BLAs, MAAs, and responses to regulatory questions • ensure timely, high-quality delivery of statistical analyses, datasets, TFLs, and clinical study reports • oversee CRO and vendor strategy for data management and programming • 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 • build, mentor, and retain a high-performing, multidisciplinary team across biostatistics, data management, and statistical programming • partner closely with Clinical Development, Clinical Operations, Regulatory Affairs, Translational Medicine, Medical Affairs, and Commercial teams.

🎯 Requirements

• PhD (preferred) or MS in Biostatistics, Statistics, Mathematics, or a related quantitative discipline • 15+ years (with PhD) or 18+ years (with MS) of experience in biostatistics within biotech or pharmaceutical development • 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 • 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 • 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.

🏖️ Benefits

• annual bonus • stock-based long-term incentives • medical benefits • dental benefits • vision benefits • retirement plans • wellness stipend • flexible time off