Associate Director, Biostatistics

Serve as the statistical expert for major clinical development program(s), providing consultation and leadership in establishing the strategic direction for the program(s). Oversee all statistical activities for major clinical program(s) to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Provide strategic and expert statistical consultation to drug development, including development plans, complex study designs, cross-study analyses, statistical methodology, data analyses and interpretations, and regulatory submissions. Establish and drive program functional strategy for resourcing, processes and standards to maximize efficiency and global data integratability. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Work on complex problems or data requires an in-depth evaluation of various factors. Implement strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establish and assure adherence to budgets, schedule, work plans, and performance requirements. Serve as the statistical expert for major clinical development program(s), providing consultation and leadership in establishing the strategic direction for the program(s). Promote, evaluate, and implement as appropriate innovative clinical trial designs and efficient analysis methodologies. Ability to identify the most critical aspects of a problem/issue and use competitive intelligence to influence clinical development strategies. Oversee all statistical activities for major clinical program(s) to ensure timely and accurate delivery of statistical designs, analyses, reports and regulatory submissions. Utilize appropriate internal and external resources to achieve short term and long term strategic functional goals, negotiating project timelines given constraints. Leverage standardized analysis methods and reporting standards to maximize global data integratability; identify best practices for utilization across programs. Provide statistical leadership and support for regulatory meetings, submissions and follow up, including strategic risk assessment based on statistical analyses and principles. Identify and interact with external statistical experts for issues related to study design, methodology and results. Collaborate/lead in the development of compound/program-level sourcing/vendor strategies and provide oversight of statistical services, ensuring overall quality. Assess, communicate and propose solutions for internal, external resource and/or quality issues that may impact deliverables/timelines at the program level. Provide inputs for planning and management of external budgets related to statistical deliverables. Participate in external professional initiatives and organizations such as ASA, PhRMA, DIA, etc. to identify industry best practices and its applicability in Nektar Therapeutics. Other duties as assigned