Associate Director, Statistical Programming

About the Company

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, hyperphagia in Prader-Willi syndrome, endometriosis*, and uterine fibroids*, as well as a robust pipeline of compounds in mid- to late-phase clinical development. For over three decades, Neurocrine has applied unique insights into neuroscience and the interconnections between brain and body systems to treat complex conditions.

*In collaboration with AbbVie

About the Role

Serves as the Program Lead Statistical Programmer on one or more clinical programs and provides statistical programming leadership and strategic input to plans and objectives for the area of responsibility. Brings strong technical expertise across clinical development, with an emphasis on building efficient, fit-for-purpose approaches for early-phase studies where precedent may be limited and study designs or data may require tailored solutions. Provides expert guidance on analysis, reporting, regulatory submission deliverables, programming processes, tools, standards, and procedures. Partners cross-functionally to strengthen programming practices, support effective progression of programs from early development into later-stage studies, and ensure high-quality, scalable delivery. May have direct reports.

Responsibilities

• Provides strategic and technical leadership for statistical programming across one or more clinical programs, helping establish effective ways of working, clear expectations, and scalable practices that support the broader organization.
• Serves as the clinical program lead statistical programmer on one or more clinical programs and supports studies across the development lifecycle, including early-phase and proof-of-concept work.
• Develops and implements efficient, fit-for-purpose approaches for analysis, reporting, and regulatory submission deliverables, including annotated CRFs, dataset transport files, define documents, and regulatory reviewer guides that appropriately address study-specific considerations.
• Creates clear frameworks for programming strategy, resourcing, analysis, and delivery, and identifies opportunities to improve processes and technology to enable consistent, scalable execution across the portfolio.
• Builds and shares expertise in specialized clinical data and study considerations, which may include PK/PD, biomarkers, local and specialty laboratories, healthy volunteers, patients, age groups, and other special populations.
• Provides strong technical statistical programming leadership to the Statistical Programming function within Biometrics and acts as a technical resource and thought partner for statistical programmers and cross-functional stakeholders.
• Plays a lead role in the development and implementation of programming standards and conventions and contributes to building statistical programming infrastructure that supports quality, consistency, and efficient delivery.
• Continually assesses statistical programming workload and project requirements to ensure appropriate programming resources are available to meet project timelines and business priorities.
• Plays a lead role in hiring, training, coaching, and oversight of in-house and contract statistical programmers supporting the analysis and reporting of clinical and nonclinical data for corporate development programs.
• Contributes to the assessment of department software needs and identifies opportunities to use tools and technology to improve the scalability, consistency, and efficiency of statistical programming processes.
• Contributes to the identification and selection of external vendors that provide specialized services to support the statistical programming function and oversees and validates vendor programming activities, including CDISC implementation, analysis reporting, and programming conventions.
• Plays a lead role in the creation and validation of e-submission requirements, ensuring deliverables are compliant, clear, high quality, and appropriately tailored to the study and regulatory context.
• Serves as primary/lead programmer for agency reporting deliverables such as DSUR/Annual Report and IB updates and performs the function of lead and/or quality control statistical programmer on projects as needed.
• Performs other duties as assigned.

Requirements

• BS/BA degree in computer science, mathematics, statistics, or related field AND 10+ years of experience in the biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS (Base, Stat, Macro, graph) required. Experience serving in a managerial role, including hiring, development, evaluation, and support of junior staff and contractors.
• OR Master’s degree in computer science, mathematics, statistics, or related field AND 8+ years of similar experience noted above.
• OR PhD in computer science, mathematics, statistics, or related field AND 6+ years of similar experience noted above.
• Recognized as an internal thought leader with strong technical and business expertise within a strategic organization.
• Broad understanding of the processes, procedures, and systems used to accomplish the team’s work and familiarity with the underlying concepts in other disciplines within the function.
• Applies in-depth understanding of how own discipline integrates within the function and understands contribution to Neurocrine's achievement of business objectives.
• Identifies and resolves technical, operational, and organizational problems related to own discipline.
• Advanced understanding of relational databases and experience working with complex data systems.
• Frequently works cross-functionally as the representative for their area.
• Strong leadership, coaching, and development skills with demonstrated proficiency in hiring, training, and supervision of in-house and contract statistical programmers.
• Strong organizational and time management skills with the ability to work independently and coordinate workload under pressure in a team environment to meet established deadlines.
• Proficiency with Microsoft Office Suite (Word, Excel, and PowerPoint).
• Working knowledge of SDTM and ADaM datasets and the development of integrated databases.
• Knowledge of regulatory requirements for dataset submissions (including SAS and CDISC standards) and relevant hands-on experience.
• Advanced SAS programming skills and expertise in the development and implementation of statistical programming SOPs and processes in a clinical environment.
• Knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems.
• Strong negotiation and influencing skills.
• Excellent project management skills.
• Excellent communication skills.

Pay

The annual base salary we reasonably expect to pay is $171,800.00 - $235,000.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity-based long-term incentive program.

Benefits

• Retirement savings plan (with company match).
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits to include medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.