Clinical Outcomes Solutions logo
Clinical Outcomes Solutions

A global research consulting group providing 360° support & services across all facets of clinical outcomes research.

Principal Statistical Programmer

Software EngineerSoftware EngineerFull TimeRemoteLeadTeam 51-200H1B SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

28 days ago

Salary

0

Seniority

Lead

Postgraduate Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

Principal Statistical Programmer

Clinical Outcomes Solutions

• 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 • 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

Job Requirements

  • 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)
  • 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
  • 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

Benefits

  • Health insurance
  • Retirement plans
  • Paid time off
  • Flexible work arrangements
  • Professional development

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