Associate Director, Statistical Programming

Neurocrine Biosciences; San Diego (CA); On-site; USD 172,000 - 235,000; Full time

Benefits offered by this job

Retirement savings plan

Paid vacation

Holiday and personal days

Paid caregiver/parental and medical-le

Job summary

Neurocrine Biosciences in San Diego is seeking a Senior Statistical Programmer Lead to guide statistical programming across one or more clinical programs. You will provide strategic and technical leadership, ensuring high-quality analysis, reporting, and regulatory submission deliverables.

The role requires a strong SAS background, 10+ years in biopharma, and a track record in managing programmers. Collaboration with cross-functional teams is essential for scalable, compliant execution.

Qualifications

• BS/BA in computer science, mathematics, statistics or related field and 10+ years in biopharma/CRO as statistical programmer with SAS expertise.
• Experience in a managerial role and in hiring, coaching, and overseeing staff.
• Strong understanding of SDTM/ADaM datasets and regulatory requirements for submissions.

Responsibilities

• Provide strategic and technical leadership for statistical programming across clinical programs.
• Lead programming deliverables for regulatory submissions and supports audits and inspections.
• Hire, mentor, and oversee in-house and contract programmers to ensure timely, compliant results.

Skills

SAS

Leadership

Cross-functional collaboration

Regulatory submissions

Education

BS/BA in Computer Science / Mathematics / Statistics

Tools

SAS (Base/Stat/Macro)

CDISC (SDTM/ADaM)

Regulatory submission tools

Job description

Who We Are:

Neurocrine Biosciences is a leading biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are 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 including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For more than 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, Facebook and YouTube. (*in collaboration with AbbVie) At Neurocrine, strong leadership drives both business results and team success. We look for leaders who think strategically, anticipate what’s ahead and set clear direction, while building and empowering high-performing teams. Successful leaders foster an environment where people are motivated to do their best work and deliver meaningful, measurable impact through sound decision-making and accountability.

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.

Your Contributions (include, but are not limited to):

• 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:

• Typical Experience or Education: BS/BA degree in a 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.
• Experience in the hiring, development, evaluation and support of junior staff and contractors OR Master's degree in a computer science, mathematics, statistics, or related field AND 8+ years of similar experience noted above OR PhD in a computer science, mathematics, statistics, or related field AND 6+ years of similar experience noted above OR Previous managerial / functional management experience also required.
• Recognized as an internal thought leader with strong technical and business expertise within a strategic organization.
• Requires 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/problems relating 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.
• Ability to effectively lead a team of statistical programmers with demonstrated proficiency in the 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, and 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.
• Neurocrine Biosciences is an EEO/Disability/Vets employer.
• We are committed to building a workplace of belonging, respect, and empowerment, and we recognize there are a variety of ways to meet our requirements.

Salary and Benefits:

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.

• 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

We are a top place to work.

Neurocrine Biosciences was named one of the FORTUNE Best Workplaces in Biopharma 2025. We were also named a Great Place to Work Certified company. 2025 Fortune Media IP Limited. All rights reserved. Used under license.

Our Values:

• PASSION: We are driven and love what we do. We are committed to our goals and to making a difference.
• INTEGRITY: We do the right thing for patients and our community. We take accountability. We speak up.
• COLLABORATION: We trust one another. We are inclusive. We are respectful. We are transparent. Together we succeed.
• INNOVATION: We seek and create optimal solutions.
• TENACITY: We do not quit. We adapt. We accomplish what others cannot.

Come join our team during this exciting time of growth and opportunities!