Principal Statistical Programmer FSP

TREIZE-QUARANTE (1340); London; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading company in software development is seeking a Principal Statistical Programmer to oversee clinical development programs. This role involves generating analysis datasets, developing SAS programs, and ensuring compliance with regulatory guidelines. Ideal candidates will have extensive experience in statistical programming and a strong understanding of CDISC standards. Join a dynamic team in London and contribute to impactful clinical research.

Qualifications

• 7+ years of experience as a Statistical Programmer in a clinical development environment.
• Expertise in SAS programming and clinical statistical procedures.
• Extensive experience with CDISC standards and regulatory requirements.

Responsibilities

• Generate analysis dataset specifications and develop SAS programs for datasets.
• Deliver high-quality programming outputs and maintain SAS programs.
• Collaborate with internal and external partners to meet project timelines.

Skills

SAS programming

Communication

Leadership

Education

Bachelor's degree in computer science, data science, mathematics, or statistics

Tools

R

Python

Java

Shiny

Markdown

Unix/Linux

git

Job description

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Position Overview

The Principal Statistical Programmer works independently with minimal supervision, tracking progress and providing expert technical support to team members. The role involves working on clinical development programs across different therapeutic areas, overseeing CRO programmers, and ensuring high-quality data summaries. Responsibilities include implementing reporting and analysis activities for clinical trials, with a focus on secondary data evaluation, HTA analyses, publications, and exploratory analyses.

Responsibilities

• Generate analysis dataset specifications, datasets, review guides, and define.xml files for multiple studies.
• Develop SAS programs for datasets, listings, tables, and graphs.
• Deliver high-quality programming outputs, maintaining and validating SAS (and potentially R) programs.
• Program outputs for HTA dossiers, publications, and exploratory purposes.
• Understand and process data structures (CDISC or non-CDISC).
• Follow regulatory guidelines, including good clinical practice and electronic submissions.
• Contribute to standards creation, maintenance, documentation, and validation.
• Review and author data transfer specifications for external vendors.
• Collaborate with internal and external partners to meet project timelines.
• Review and author SOPs and work instructions related to statistical programming.

Qualifications

• Bachelor's degree in computer science, data science, mathematics, or statistics.
• 7+ years of experience as a Statistical Programmer in a clinical development environment.
• Expertise in SAS programming and clinical statistical procedures.
• Extensive experience with CDISC standards and regulatory requirements.
• Experience supporting regulatory submissions and HTA dossiers is a plus.
• Ability to work independently with excellent communication and leadership skills.

Preferred Skills

• Proficiency in R, Python, Java, Shiny, Markdown, Unix/Linux, git.

Additional Details

Location: London, England, United Kingdom

Employment type: Full-time

Seniority level: Mid-Senior level

Job function: Information Technology

Industries: Software Development