Executive Director – Biostatistics, Data Sciences

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

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.

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.