Principal Analyst, Statistical Programming

Role Summary

Lead role in designing, developing, testing, maintaining, validating, and documenting SAS programs to evaluate clinical data and meet project requirements for SAS statistical programming across clinical and non-clinical studies. Provide advanced technical expertise to the development of programming standards and procedures. This role is on-site at a San Diego area campus.

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

Qualifications

• 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. OR
• Master’s degree in computer science, mathematics, statistics, or related discipline AND 4+ years of similar experience noted above OR
• 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