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Principal statistical programmer fsp

London
TREIZE-QUARANTE (1340)
Statistical programmer
Posted: 11 June
Offer description

Join to apply for the Principal Statistical Programmer FSP role at TREIZE-QUARANTE (1340).

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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

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