The Principal Statistical Programmer leads SAS and R programming for clinical trials, ensuring compliance, quality, and effective communication with stakeholders.
The Principal Statistical Programmer works independently with only concept-level instruction and minimal supervision, tracks progress, and provides expert technical support to team members. This role also includes routinely briefing management on accomplishments, status, and issues, and serving as a project lead Statistical Programmer on clinical teams.
ResponsibilitiesKey Responsibilities:
- Provide technical and project management leadership in SAS programming for analysis and reporting of complex clinical trial data, including Tables, Listings, and Figures (TLFs), and regulatory submissions (SDTM, ADaM in CDISC format)
- Lead the development, review, and approval of documentation supporting data analysis, reporting, and regulatory submissions
- Ensure compliance with company SOPs and regulatory requirements (FDA, ICH, GCP)
- Participate in and lead technical meetings with internal and external stakeholders (e.g., CROs, FDA, EMA, partners)
- Perform quality control (QC) and validation of SAS programs and outputs developed by other programmers
- Review and contribute to define.xml and ADaM Reviewer’s Guides
- Maintain and review study documentation per standard processes
- Develop, test, and maintain global SAS utility programs and tools
R Programming Responsibilities:
- Develop and maintain R programs for data manipulation, statistical analysis, and exploratory analysis in clinical trials
- Generate TLFs using R tools (e.g., tidyverse, ggplot2, rtables, rmarkdown/quarto) where appropriate
- Support reproducible research workflows using R Markdown or Quarto
- Assist in automation and optimization of clinical programming workflows using R
- Collaborate with biostatistics and data management teams to implement statistical methods in R
- Perform QC and validation of R-based outputs in alignment with regulatory expectations
- Contribute to integration or migration of SAS workflows into R environments, where applicable
- Maintain proper documentation and validation records for R programs
Technical and Communication Skills:
- Proven expertise in SAS programming, including:
- Base SAS, SAS/STAT, SAS/GRAPH
- Macro programming
- Clinical trial reporting and submission standards
- Working knowledge / hands-on experience with R programming, including:
- Data manipulation (dplyr, tidyr)
- Visualization (ggplot2)
- Reporting (R Markdown / Quarto)
- Exposure to clinical trial R ecosystems (e.g., pharmaverse packages such as admiral, rtables – preferred)
- Understanding of CDISC standards (SDTM, ADaM) and regulatory submission requirements
- Familiarity with validation and GxP considerations for R (nice to have)
- Experience with version control systems (e.g., Git) is a plus
Strong written and verbal communication skills with the ability to clearly explain complex technical concepts
Preferred Education and Experience:
- MS in Biostatistics or related field with 8+ years of pharmaceutical/clinical trial experience, or
- BS in Biostatistics or related field with 10+ years of relevant experience
- Experience with BLAs, MAAs, and regulatory submissions is highly desirable
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