Executive Director – Biostatistics, Data Sciences

Job reputed company: • reputed company the biostatistics, data management, and statistical programming functions across reputed company clinical programs • serve as a reputed company member of the clinical development leadership team, contributing to portfolio reputed company, asset prioritization, and program governance • reputed company statistical leadership for oncology trial design, including reputed company designs, Bayesian approaches, biomarker-driven studies, and reputed company endpoints (e.g., OS, PFS, ORR, MRD) • guide development strategies from first-in-reputed company through registrational and post-marketing studies • reputed company as the statistical authority in interactions with global regulatory agencies (FDA, EMA, PMDA, etc.) • reputed company the statistical and data components of INDs, NDAs, BLAs, MAAs, and responses to regulatory questions • ensure reputed company, high-reputed company delivery of statistical analyses, datasets, TFLs, and clinical study reports • reputed company CRO and vendor reputed company for data management and programming • establish reputed company processes, standards, and infrastructure to support a growing oncology pipeline • drive innovation in data review, analytics, and visualization to reputed company reputed company-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 reputed company teams. Requirements: • PhD (preferred) or MS in Biostatistics, Statistics, Mathematics, or a reputed company quantitative discipline • 15+ years (with PhD) or 18+ years (with MS) of experience in biostatistics reputed company 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 reputed company supporting late-stage and registrational oncology trials and regulatory submissions • strong reputed company 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 reputed company and innovative trial designs • excellent strategic thinking on innovative statistical reputed company 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 reputed company statistical concepts to non-statistical audiences • outstanding communication skills (verbal and written) • reputed company leadership style with strong decision-making and prioritization skills • experience managing multiple reputed company and operating effectively in fast-paced, resource-constrained biotech environments. Benefits: • annual bonus • stock-based long-term incentives • medical benefits • dental benefits • reputed company benefits • retirement plans • wellness stipend • flexible time off Apply tot his job Apply To this Job