Senior Director, Statistical Programming

Neurocrine Biosciences; San Diego (CA); On-site; USD 228,000 - 311,000; Full time

Benefits offered by this job

Retirement plan

Paid vacation

Paid holidays

Personal days

Parental leave

Medical leave

Health benefits

Job summary

Neurocrine Biosciences seeks a Senior Director of Statistical Programming to lead the statutory programming function across clinical programs. The role oversees strategic direction, staffing, and vendor management for data analysis and regulatory submissions.

The position requires extensive SAS programming expertise, deep SDTM/ADaM knowledge, and experience delivering analyses for NDAs/BLAs in a matrix environment. On-site in San Diego with competitive compensation and bonus opportunities.

Qualifications

• 15+ years in biopharmaceutical or CRO with leadership in statistical programming.
• Experience delivering stats programs for regulatory submissions.
• Strong leadership, budgeting, vendor management and cross-functional collaboration.

Responsibilities

• Sets vision and strategic direction for Statistical Programming.
• Oversees and manages data analysis and reporting across studies.
• Manages external vendors and in-house staff; ensures timeliness and quality.
• Develops and maintains SOPs; trains programmers and ensures documentation.

Skills

SAS programming

SDTM/ADaM

Regulatory knowledge

Programming validation

Vendor management

Leadership

Education

BS/BA in CS/Math/Stats

MS/PhD in CS/Math/Stats

Tools

Statistical software stack

Job description

## Senior Director, Statistical ProgrammingApply: On-Site: US CA San Diego: Posted Today: R7360## 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:Leads departmental initiatives by providing vision, strategic planning, and management. Offers guidance and mentorship to statistical programming team members. Manages planning and execution of Statistical Programming for data analysis and reporting across Neurocrine studies. Acts as the expert resource within Neurocrine for Statistical Programming matters across departments.\\_## Your Contributions (include, but are not limited to):* Implements vision and strategic direction for Statistical Programming* Creates statistical programming strategy input for the preparation of marketing applications (e.g., New Drug Application (NDA) submissions to the FDA)* Oversees and monitors statistical system landscape, monitoring industry trends, evaluating novel tools for potential company use and ensuring that systems and resourcing models are scalable for the future* Responsible for ensuring that the company's clinical data and statistical software needs are scalable with oversight on all aspects of acquiring and installing new software, including the identification of software requirements, and oversight of the installation, validation, and maintenance* Oversees long-term workforce planning for the department ensuring enough and right balance of in-house and contract resources are available to support the analysis and reporting of data from clinical studies for all current and future corporate development programs* Manages all external vendors from identification, selection, monitoring contractual work product quality standards and timeliness and ending relationships as needed* Implements and manages the development and revision of department statistical programming standard operating procedures.* Trains both in-house and contract statistical programmers on standard operating procedures and that all required training is completed and documented* Builds relationships with internal and external customers* Develops and manages statistical programming budget and vendor budgets; oversees proposal requests from external vendors and negotiates costs, as appropriate* Performs other job related duties as assigned## Requirements: **Typical Experience or Education:*** BS/BA degree in a computer science, mathematics, statistics, or related field AND 15+ years of experience in the biopharmaceutical or Contract Research Organizations (CRO) industry with extensive experience in a leadership role, leading teams of in-house and/or contract statistical programming management / staff. OR* Master's degree in a computer science, mathematics, statistics, or related field AND 13+ years of similar experience noted above OR* PhD in a computer science, mathematics, statistics, or related field AND 10+ years of similar experience noted above* Common Knowledge & Skills:* Acts as a \"trusted advisor\" across the company and may be recognized as an external expert* Provides strategy, vision and direction regarding issues that may have company-wide impact* Requires in-depth knowledge of the functional area, business strategies, and the company’s goals* Must be self-motivated and detail-oriented* Ability to quickly learn and think independently* Excellent leadership, coaching and employee 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* Excellent interpersonal & communication skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company* Ability to work with a team of individuals to meet organizational goals* Possesses industry-leading knowledge pertaining to clinical and regulatory aspects of a pharmaceutical company.* Evaluates key business / scientific challenges and completes complex, ambiguous initiatives having cross-functional impact* Ability to apply advanced analytical thought and judgement* Ability to work in a cross-functional team and a matrix environment* Excellent 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* Excellent interpersonal skills and problem-solving capabilities **Job Specific Knowledge & Qualifications:*** Expert knowledge of industry systems landscape and proven ability to identify and evaluate potential systems for company use.* Expertise in SAS programming skills and the development and implementation of statistical programming procedures and processes in a clinical development environment.* Advanced knowledge of regulatory guidelines and requirements relevant to the design, analysis, reporting, and submission of clinical studies and clinical study data* Advanced knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems* Solid knowledge of SDTM and ADaM datasets and the development of integrated databases* Proven track record of delivering statistical analysis in supporting the drug development application process* Proven success with end to end vendor management* Extensive systems identification and evaluation experience #LI-KM3Neurocrine 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 don’t line up to exactly what we have outlined in the job description.\\_The annual base salary we reasonably expect to pay is $228,000.00-$311,000.00. 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 35% 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.