Who We Are:
At Neurocrine Biosciences - voted one of San Diego's top places to work in 2018 - we pride ourselves on having a strong, distinctive 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 patient suffering and enhance lives.
What We Do:
Neurocrine Biosciences is a biopharmaceutical company focused on developing treatments for neurological and endocrine related disorders.
About the Role:
The Principal Biostatistician will serve as the overall statistical lead on one or more clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies.
Your Contributions (include, but are not limited to):
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 subteam (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.
Reviews and approves clinical study database data validation specifications, data review plans, coding guidelines, and data transfer agreements.
Prepares, reviews, and approves statistical analysis plans.
Works closely with statistical programmers to ensure that statistical methods are implemented correctly in statistical programs and collaborates with programmers in developing formats and specifications for summary tables, figures, and listings.
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, including consulting and statistical analysis.
Assists in the development of department standard operating procedures and 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.
Researches, identifies, develops, and implements new and innovative statistical methods for the analysis of clinical study data and adaptive study designs.
MS or PhD in statistics or biostatistics, or a related discipline, with a minimum of 7 year's relevant experience or equivalent education and experience.
Demonstrated ability to provide statistical leadership and strategic input regarding the overall drug development plan and commercialization activities.
Strong organizational skills and proven ability to effectively lead a project to successful completion.
Demonstrated experience in the design, analysis, and reporting of clinical studies.
Strong working knowledge of the SAS programming with a specific emphasis on SAS procedures used in programming statistical analyses commonly used in the analysis of clinical study data.
Significant hands-on experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets.
Thorough knowledge of regulatory guidelines relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data. Experience in interacting directly with regulatory authorities highly desirable.
Excellent oral and written communication skills are required.
Must be able to travel up to 5% of the time per year. Requires the ability to sit or stand while working on a PC for long periods of time.
Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.