Executive Director – Biostatistics, Data Sciences
Job 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
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• 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
Apply tot his job
Apply To this Job