Senior Director, Biostatistics

Role: Senior Director, Biostatistics (DQS Lead) Responsibilities / Accountabilities Leads biostatistics and serves as DQS Lead for the global program team, translating complex data into decision-shaping insights for program strategy, governance, and regulatory decisions. Provides statistical input to development strategies and implementation plans for product development and/or market access objectives in a global organization. Provides expertise and guidance with cross-functional teams on study design, analysis strategy, and best practices across planning, execution, interpretation, and regulatory submission of clinical projects and studies. Guides and manages statisticians to ensure high-quality, timely deliverables. Manages resources, sets priorities, ensures consistency and adherence to standards. Through matrix leadership across DQS functions, ensures fit-for-purpose execution, proactively manages risk, and partners with cross-functional leaders to drive defensible decisions that accelerate delivery of medicines to patients. Leads and develops teams in a matrixed global environment; sets priorities and allocates resources to protect portfolio milestones; partners cross-functionally to ensure compliant, scalable execution and an inclusive culture. Key Responsibilities Develops and reviews statistical analysis plans aligned with study objectives and regulatory requirements. Provides expert statistical guidance into clinical development plans, clinical study protocols, clinical study reports, regulatory submission documents, and publications. Provides statistical leadership and support for feasibility assessments, clinical development plans, complex study designs, regulatory meetings, submissions, and follow-up. Manages relationships with external partners and vendors to ensure quality and timeliness of statistical deliverables. Leads development and adaptation of new statistical methodologies, staying current with regulatory guidance. Leads and oversees the biostatistics team to deliver statistical analysis plans and reports for clinical trials. People Management Accountabilities Provides leadership and direction through multiple levels of managers and/or expert-level individual contributors across departments. Directly accountable for performance/results of a large department, region/key market, or complex/multiple sites. Develops function strategy and contributes to broader organization strategy. Compensation & Benefits (as stated) Princeton, NJ: $249,480–$302,305 (starting range). Health Coverage (medical, pharmacy, dental, vision); Wellbeing programs; Financial well-being/protection (401(k), disability, life insurance, etc.); Paid Time Off (flexible time off/vacation options depending on location/role), plus additional time-off and Global Shutdown (eligibility-based). #J-18808-Ljbffr Scorpion Therapeutics