Sr. Principal Analyst, Statistical Programming

Neurocrine Biosciences • San Diego, CA

22h

About The Position

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.

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

Responsibilities

• 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

Benefits

• 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.

What This Job Offers

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