Sr. Principal Analyst, Statistical Programming

Biopharma Careers; San Diego (CA); On-site; USD 157,000 - 214,000; Full time

Job summary

Neurocrine Biosciences seeks a senior statistical programmer to lead major programming efforts for clinical programs. You will design, validate, and maintain SAS programs to analyze clinical data, and mentor a team of programmers across biometrics functions.

Strong leadership and vendor management are essential. Ideal candidates have extensive SAS and CDISC experience, with a track record of delivering on deadlines in a regulated biopharmaceutical environment.

Qualifications

• BS/BA degree in computer science, mathematics, statistics, or related discipline with 8+ years of statistical programming experience in biopharmaceuticals or CROs.
• Master’s or PhD with relevant experience can substitute as noted.
• Experience supervising or leading teams and managing large projects with external vendors.

Responsibilities

• Provide expert technical leadership across Biometrics and lead statistical programming efforts.
• Mentor a team of statistical programmers for clinical and nonclinical study data analyses.
• Oversee end-to-end programming work-streams across multidisciplinary programs company-wide.

Skills

SAS programming

CDISC data structures

Leadership

Project management

Communication

Analytical thinking

Regulatory knowledge

Education

BS/BA in computer science, mathematics, statistics, or related discipline

Master’s degree in computer science, mathematics, statistics, or related discipline

PhD in computer science, mathematics, statistics, or related discipline

Tools

SAS

R

CDISC standards

Job description

Who We Are:

At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs.

What We Do:

Neurocrine Biosciencesis a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, classic congenital adrenal hyperplasia, 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 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 and Facebook . ( *in collaboration with AbbVie )

About the Role:

Leads major statistical programming efforts for clinical program area of responsibility. Develops and recommends system capabilities roadmap for in-house development and external vendor selection process. Acts as a system expert in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts. Provides expert-level technical advice for all aspects of the program development process, tools and software, standards and procedures.

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

• Provides expert technical leadership across multiple functions serving as the key representative for Biometrics
• Contributes to the development of Biometrics functional strategy and serves as system expert for Statistical Programming efforts
• Leads and mentors a team of statistical programmers to support the analysis and reporting of data from clinical and nonclinical studies for all corporate development programs
• Leads end-to-end statistical programming work-streams on multidisciplinary program teams company-wide
• Provides technical direction in the development and implementation of programming standards and conventions, building statistical programming infrastructure
• Provides workforce planning recommendations based on project workloads in order to ensure appropriate programming resources are available to complete tasks in a timely manner
• Manages vendor selection processes and validates vendor programming activities such as CDISC implementation, analysis reporting, and programming conventions
• Supports creation and validation of e-submission requirements (i.e. annotated CRF, datasets files, define documents)
• Serves as primary/lead programmer for agency reporting deliverables such as DSUR/Annual Report and IB updates
• 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 discipline AND 8+ years in the Biopharmaceutical (or CRO) industry as a statistical programmer with advanced knowledge of SAS, (Base, Stat, Macro, graph), CDISC data structures. In addition, must have at least 2 years of experience serving in a supervisory or lead capacity. Experience managing large projects and external vendors. OR
• Master’s degree in computer science, mathematics, statistics, or related discipline AND 6+ years similar experience noted above OR
• PhD degree in computer science, mathematics, statistics, or related discipline AND 4+ years similar experience noted above
• Anticipates business and industry issues; recommends relevant process / technical / service improvements
• Demonstrates broad expertise or unique knowledge
• Considered an expert within the company and may have external presence in area of expertise
• Applies in-depth expertise in discipline and broad knowledge of other closely related areas to improve efficiency of team
• Ability to work as part of and lead multiple teams
• Good leadership, mentoring skills and abilities typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture and longer-term impact on division/company
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management, strong project leadership skills
• Expert knowledge of the following:
• Developing and implementing statistical programming SOPs and processes in a clinical environment
• Relational databases and complex data systems.
• Industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar
• SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains
• Knowledge of all aspects of writing, validating, and documenting statistical programs, and of creating integrated programming libraries and systems
• Proven experience in multi-discipline, cross-functional project management in a clinical, highly regulated environment
• Track record of success with effectively organizing and managing multiple assignments with challenging timelines across multiple personnel

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Neurocrine Biosciences is an EEO/Disability/Vets employer.

The annual base salary we reasonably expect to pay is $156,900.00-$214,000.00. 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 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.