Associate Biostats Director, Osavampator VMAT

Overview

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, endometriosis and uterine fibroids, as well as a robust pipeline in mid- to late-phase clinical development across core therapeutic areas.

For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders. For more information, visit , and follow the company on Linked In, X and Facebook. (in collaboration with Abb Vie)

Serves as the overall statistical lead on multiple clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies to expedite the conduct and evaluation of clinical trials and basic research. Leads statistical analysis and maintains standards across studies within a clinical program. Maintains expertise in new and innovative statistical analysis methodology. Interacts with key opinion leaders on protocol design.

Oversees and directs the biostatistics team responsible for the analysis and reporting of data from clinical studies.

• Oversees contract biostatisticians to support the analysis and reporting of data from clinical studies for clinical development programs
• Provides statistical leadership and strategic input to the Dev Core Team in all areas of drug development and commercialization, including the overall clinical development plan, publication planning, and studies
• Represents Biometrics on one or more Dev Core Team or clinical sub team (as appropriate for the clinical program)
• Collaborates with Clinical Development, Medical Writing, and Regulatory Affairs project team members and consultants in the development of clinical study protocols, statistical analysis plans, and clinical study reports
• Identifies appropriate, efficient experimental designs, defines analysis endpoints, develops randomization plans, and determines appropriate statistical methods of analysis for clinical studies
• Represents Biostatistics in interactions with regulatory agencies
• Prepares, reviews, and approves statistical analysis plans
• Oversees and monitors CRO performance of statistical analyses and programming to ensure that timelines are met, resource issues are identified and resolved, and all applicable data and programming standards are adhered to
• Provides biostatistical support to nonclinical, medical affairs, and commercial areas of the company as needed
• Assists in the development of department standard operating procedures, statistical analysis plan and report templates, data standards, and selection and implementation of statistical software
• Mentors junior members of the biostatistics team and supervises their work on an as-needed basis
• Reviews, approves and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs
• Assumes a leadership role in clinical program(s), with the responsibility of ensuring that the statistical requirements are met for all projects in the program(s)
• Performs other duties as assigned

• Master’s degree in statistics, biostatistics or related discipline AND 11+ years of experience with Phase 1 through Phase 4 clinical studies and observational studies, and the development of drug development strategies in the pharmaceutical industry setting, particularly the design, analysis and reporting of clinical studies. Demonstrated experience in SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
  
  Direct experience interacting with regulatory authorities. OR
• PhD in statistics, biostatistics or related discipline AND 8+ years of similar experience as noted above
• Considered an expert within the company and may have external presence in area of expertise
• Applies in-depth knowledge of own function, business / commercial / scientific expertise to solve critical issues successfully and innovatively
• Ability to work as part of and lead multiple teams
• Sees broader picture and longer-term impact on division/company
• Excellent leadership, coaching and development skills
• Strong negotiation and…