Sr. Director, Biostatistics

Role Summary

Sr. Director, Biostatistics at Neurocrine Biosciences. Provides strategic planning and management for selected projects and departmental initiatives; directs biostatistics activities for clinical or observational studies from design through interpretation; serves as subject matter expert and provides leadership to support studies, regulatory submissions, and publications.

Responsibilities

• Supports the creation of strategic plans and the implementation of corporate/organizational policies in Biostatistics or related quantitative science areas under supervision
• Oversees the responsible area, including day-to-day management activities as well as technical leadership and coaching for the staff
• Serves as the functional area lead for one or more Neurocrine clinical or observational study programs, including serving as lead biostatistician or epidemiologist, working in cross-functional teams to develop the drug development strategy, and coordinating with data management and statistical programming on activities related to clinical studies and other analysis projects
• Provides input and support to the development of clinical plans, publications, and studies under the direction of senior analytics and data sciences leadership
• Researches, develops, and implements statistical or observational research methods appropriate to study design and objectives and consistent with current regulatory standards and requirements
• Participates in regulatory submission planning, including data submission strategies and integrated summaries
• Represents Neurocrine as the functional representative in discussions and meetings with regulatory agencies
• Develops functional processes and procedures, including the writing and review of department standard operating procedures
• Makes final decisions on administrative or operational matters related to the functional or expertise group under supervision and ensures effective achievement of objectives
• Performs other duties as assigned

Qualifications

• Masters degree in statistics, biostatistics, epidemiology or similar field preferred and 13+ years experience with Phase 1 through Phase 4 clinical studies and observational studies, and development of drug development strategies in the pharmaceutical industry; extensive leadership experience required OR
• PhD in statistics, biostatistics, epidemiology or related discipline preferred and 10+ years of similar experience
• Significant expertise in design, analysis and reporting of clinical studies, including innovative and adaptive study designs and advanced analytical methods
• Significant experience with regulatory submissions and interactions with regulatory agencies
• Extensive experience with Phase 1 through Phase 4 clinical studies and observational studies and drug development strategies
• Demonstrated leadership skills as biostatistics lead on multiple clinical programs
• Thorough knowledge of regulatory guidelines related to design, analysis, reporting, and submission of clinical studies
• Ability to manage multiple projects and adapt to changing priorities
• Ability to serve as a company-wide advisor and emerging industry expert
• Strategy development and implementation within areas of responsibility
• Expert knowledge of own function with broad knowledge across functions and business impact
• Proven leadership and influencing skills across levels of the organization
• Ability to mentor and train personnel and motivate teams to achieve goals
• Strong problem-solving skills and proactive issue resolution
• Self-motivated, detail-oriented, decisive, and able to learn quickly
• Excellent interpersonal and communication skills, with ability to interact professionally with peers, management, and leadership
• Ability to work in a team to meet organizational goals

Education

• Master‚Äôs or PhD in a relevant field as noted in qualifications