Principal Analyst, Statistical Programming

Jobtailor; San Diego (CA); On-site; USD 130,000 - 190,000; Full time

Job summary

Jobtailor in San Diego, CA seeks an experienced Statistical Programmer Leader to guide SAS programming across clinical data analyses and submissions. You will lead teams and coordinate biometrics activities, ensuring CDISC compliance and robust documentation.

You will supervise and mentor programmers, drive vendor collaborations, and oversee regulatory deliverables such as DSURs, IB updates, and e-submission components. Strong leadership and strategic programming experience are essential.

Qualifications

• BS/BA in CS, math, stats, or related discipline; 6+ years biopharma or CRO statistical programming experience
• Master's degree with 4+ years, or PhD with 2+ years in relevant field
• At least three years in a supervisory or lead capacity
• Advanced SAS knowledge: Base, Stat, Macro, and Graphs
• CDISC SDTM/ADaM data structures and Define.xml expertise
• Experience managing large projects and external vendors

Responsibilities

• Lead design, development, testing, maintenance, validation, and documentation of SAS programs evaluating clinical data
• Provide advanced statistical programming leadership within Biometrics
• Serve as a technical resource for statistical programmers
• Participate in hiring, training, and oversight of statistical programmers
• Lead large, multidisciplinary projects as the primary Statistical Programming point of contact
• Oversee vendor programming activities, including CDISC implementation and analysis reporting
• Support creation and validation of e-submission requirements (annotated CRFs, datasets, define documents)
• Serve as primary/lead programmer for agency reporting deliverables (DSUR/IB updates)
• Perform lead and/or QC statistical programming as needed

Skills

SAS programming

Leadership

Project management

Communication

Analytical thinking

Problem-solving

Education

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

Master's degree in related field

PhD in related field

Tools

CDISC data standards

Define.xml

Relational databases

MS Word/Excel/PowerPoint

Job description

• Lead the design, development, testing, maintenance, validation, and documentation of SAS programs evaluating clinical data
• Provide advanced technical statistical programming leadership within Biometrics
• Serve as a technical resource for statistical programmers
• Participate in hiring, training, and oversight of statistical programmers
• Lead large, multidisciplinary projects and serve as the primary Statistical Programming point of contact
• Direct development and implementation of programming standards, conventions, and infrastructure
• Assess workload and projects to ensure programming resources are available
• Oversee and validate vendor programming activities, including CDISC implementation and analysis reporting
• Support creation and validation of e-submission requirements, including annotated CRFs, datasets, and define documents
• Serve as primary or lead programmer for agency reporting deliverables such as DSUR/Annual Report and IB updates
• Perform lead and/or quality control statistical programming on projects as needed
• Perform other duties as assigned

Requirements

• BS/BA degree in computer science, mathematics, statistics, or related discipline and 6+ years of biopharmaceutical or CRO statistical programming experience; or Master's degree and 4+ years; or PhD and 2+ years
• At least three years of experience serving in a supervisory or lead capacity
• Advanced knowledge of SAS, including Base, Stat, Macro, and graph
• Advanced knowledge of CDISC data structures, SDTM domains, ADaM data sets, and Define.xml files
• Experience managing large projects and external vendors
• Knowledge of best practices in the functional discipline and related business disciplines
• Advanced SAS programming skills and expertise developing and implementing statistical programming SOPs and processes in a clinical environment
• Knowledge of writing, validating, and documenting statistical programs and creating integrated programming libraries and systems
• Project management experience with minimum supervision
• Ability to organize and manage multiple assignments with challenging timelines across multiple personnel
• Advanced understanding of relational databases and complex data systems
• Expert knowledge of ICH guidelines, CDISC data structures, 21 CFR Part 11, and FDA guidelines
• Advanced programming skills in SAS, R, STAT, or similar
• Proficiency with Word, Excel, and PowerPoint
• Excellent computer, communication, problem-solving, analytical thinking, project management, and leadership skills
• Ability to work as part of and lead multiple teams
• Ability to meet multiple deadlines with high accuracy and efficiency

Core Competencies

Demonstrates advanced expertise in SAS programming, including Base, Stat, Macro, and graph, along with a strong understanding of CDISC data structures and regulatory guidelines. Proven ability to lead multidisciplinary projects, manage teams, and ensure high-quality statistical programming deliverables in a clinical environment.