Associate Director, Statistical Programming

Neurocrine Biosciencesis 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 companys diverse portfolio includes FDA-approved treatments for tardive dyskinesia chorea associated with Huntingtons 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 and follow the company onLinkedInX 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 whats 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. 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.

• 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.

Typical Experience or Education:

• 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

• Masters 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 teams 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 Neurocrines 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. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications dont line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $171800.00-$235000.00. Individual pay decisions depend on various factors such as primary work location complexity and responsibility of role job duties/requirements and relevant experience and 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 offered include a retirement savings plan (with company match) paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage in accordance with the terms and conditions of the applicable plans.