Principal Statistical Programmer

Role Summary

The Principal Statistical Programmer provides expert-level hands-on principal programming support and technical leadership to develop, maintain, validate and run SAS programs that access, visualize, analyze, and report clinical trial data, in accordance with statistical analysis plans, ICH guidelines, and regulatory requirements. Strong SAS/GRAPH programming expertise is required; experience with R programming for data visualization and exploratory analysis is strongly preferred.

Responsibilities

• Write programs that produce or validate tables, listings, figures and analysis datasets for clinical studies or complex integrated analyses for submission
• Develop and follow good programming practices, including adequately documenting SAS and R code
• Plan and coordinate project work to ensure timely, quality delivery across multiple projects
• Use, modify, and maintain existing SAS and R code
• Write specifications to describe programming needs
• Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency
• Stay abreast of current and new statistical programming techniques and other applicable technical advancements and assist in their implementation
• Provide input into, or lead standardization efforts (e.g., CRFs, query checks, standard statistical programs, data presentations)
• Assist or lead efforts to develop programming processes consistent with industry best practices
• Review DMP, eCRF specs, and other clinical data management documents
• Review statistical analysis plans and related documents
• Partner with or oversee CROs or Programming vendors to perform tasks
• Other duties as assigned

Qualifications

• At least 8 years‚Äô industry SAS programming experience (Pharmaceutical, Biotech, CRO) or equivalent
• Knowledge of clinical trials and experience using SAS to report results for submission
• Experience constructing technical programming specifications and producing complex, validated programs
• Strong experience with CDISC standards (SDTM, ADaM, Define.xml)
• Preferred experience in R programming
• Excellent knowledge of applied statistical methodologies
• Excellent knowledge of SAS Macro, SAS/SQL, SAS/GRAPH, and SAS/STAT
• Good communication and organizational skills
• Bachelor‚Äôs Degree required; Master‚Äôs Degree preferred
• Alignment with core values: Commitment to People, Innovation and Discovery, Sense of Urgency, Open Culture, Passion for Excellence

Education

• Bachelor‚Äôs Degree required; Master‚Äôs Degree preferred