Associate Director, Statistical Programming

Neurocrine Biosciences • San Diego, CA

1d • $171,800 - $235,000

About The Position

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.

Requirements

• BS/BA degree in a computer science, mathematics, statistics, or related field AND 10+ years of 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
• 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.

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.

Benefits

• annual bonus with a target of 30% of the earned base salary
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager