Principal Analyst, Statistical Programming

Neurocrine Biosciences • San Diego, CA

1d • $130,800 - $179,000 • Onsite

About The Position

Plays a lead role in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet the project requirements for SAS statistical programming efforts for clinical and non-clinical projects and studies. Provides advanced technical expertise to the development of programming standards and procedures. This role will be on-site at our beautiful campus, the ideal candidate will live in the San Diego area.

Requirements

• BS/BA degree in computer science, mathematics, statistics, or related discipline AND 6+ years of experience 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 three years of experience serving in a supervisory or lead capacity. Experience managing large projects and external vendors.
• Master’s degree in computer science, mathematics, statistics, or related discipline AND 4+ years of similar experience noted above
• PhD in computer science, mathematics, statistics, or related discipline AND 2+ years of similar experience noted above
• Has knowledge of best practices in the functional discipline and familiarity with the broader underlying concepts of related business disciplines
• Works to improve tools and processes within functional area
• Developing reputation inside the company as it relates to area of expertise
• Ability to work as part of and lead multiple teams
• Exhibits leadership skill and ability, typically leads lower levels and/or indirect teams
• Excellent computer skills
• Excellent communications, problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent project management skills
• Proficiency with Word, Excel, and PowerPoint is required as is the ability to communicate effectively both verbally and in writing
• 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
• Experience in project management with minimum supervision. Demonstrate ability to effectively organize and manage multiple assignments with challenging timelines across multiple personnel
• Advanced understanding of relational databases and experience working with complex data systems
• Demonstrates expert knowledge with industry standards, such as the ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Advanced programming skills in SAS, (Base, Stat, Macro, graph), R, STAT or similar
• Advanced knowledge of SDTM domains, ADaM data sets, and Define.xml files with proficiency in creating specification files for these domains

Responsibilities

• Provides advanced technical statistical programming leadership to the Statistical Programming function within Biometrics and be a technical resource for statistical programmers
• Participates in hiring, training, and oversight of statistical programmers to support the analysis and reporting of data from clinical and nonclinical studies for all corporate development programs
• Serves as the lead on projects and primary Statistical Programming point of contact on large, multidisciplinary projects company wide
• Provides technical direction in the development and implementation of programming standards and conventions, building statistical programming infrastructure
• Contributes to the assessment of workload and projects in order to ensure appropriate programming resources are available to complete tasks in a timely manner
• Oversees 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

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: Senior