Principal Biostatistician-San Diego based preferred

Who We Are:

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, but few options.

What We Do:

Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company’s diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington’s disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our 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, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:

Serves as the overall statistical lead on one or more clinical programs and will provide statistical input in design, analysis, and reporting of clinical studies to expedite conduct and evaluation of clinical trials and basic research. Leads statistical analysis and develops tracking systems to determine the efficiency of clinical trials. Interacts with clinical investigators to determine protocol design. Evaluates databases and statistical analysis programs and interacts with computer groups to determine hardware/software compatibility.

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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

Requirements:

• Master’s degree in statistics or biostatistics, or a related discipline

  and 4+ years of experience in 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. Significant experience working with CDISC and related FDA standards for specification and creation of SDTM and ADaM datasets. Pro