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
Skills Required
- Proven expertise in SAS programming including Base SAS, SAS/STAT, SAS/GRAPH
- Working knowledge with R programming including data manipulation and visualization
- Understanding of CDISC standards (SDTM, ADaM) and regulatory submission requirements
- MS in Biostatistics or related field with 8+ years of pharmaceutical/clinical trial experience
- Experience with BLAs, MAAs, and regulatory submissions is highly desirable
Cytel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Cytel and has not been reviewed or approved by Cytel.
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Healthcare Strength — Health coverage is described as comprehensive, spanning medical, dental, vision, life and disability, with FSAs/HSAs also available. Plan quality is often characterized as good to excellent, which lifts the perceived value of the overall package.
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Retirement Support — A 401(k) with employer match is consistently part of the benefits package. The plan is also characterized as well managed, contributing to a sense of baseline retirement support.
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Fair & Transparent Compensation — Overall pay is characterized as decent-to-good and broadly competitive in parts of the business, with stronger alignment noted in senior technical tracks like biostatistics and programming. The total package is often framed as respectable rather than premium.
Cytel Insights
What We Do
Cytel enables decision-makers in the life sciences to unlock the full potential of their products. From navigating uncertainty to proving value, Cytel’s 30 years of global expertise in consulting, data-driven analytics, and industry-leading software helps biotech and pharmaceutical companies transform intelligence into confident decisions. We have an uncompromising commitment to scientific rigor and high standards of operational excellence, which are channeled through our locations in North America, Europe, the United Kingdom, and Asia. Together, we enable our clients to deliver the therapies that propel humanity forward. Cytel employs a range of data science tools from biostatistics to machine learning to help executives in the life-sciences to make confident decisions powered by data. We are probably best known for being leaders in the field of adaptive clinical trial design, a subset of trial design that uses interim looks to enhance the patient safety and commercial value of pharmaceutical products. We also have specialists in Bayesian statistics, real world evidence, artificial intelligence, health economics, and a number of other research fields to ensure that academic and scientific findings can have impact on industry quickly and seamlessly. www.cytel.com
