Overview

As a Principal Statistician you’ll work on clinical trials; producing and validating datasets and outputs to excellent quality whilst adhering to deliverable timelines. Producing and reviewing Statistical Analysis Plans (SAPs), protocols and other pertinent study documentation. You will be a key contributor within the FSP team, working embedded within sponsor teams.

Responsibilities

Program and validate complex primary efficacy datasets
Program and validate complex summary tables, listings and figures, program statistical analysis tables, according to the SAP
Liaise with clients to propose alternatives or additional analyses if needed
Develop and validate macros for statistical analyses and figures
Perform stage 3 QC
Advise on complex analyses and endpoints; ensure consistency across clinical trial program
Create, validate and QC of efficacy dataset specifications for single studies, ISS/ISEs, etc.
Write ISS/ISE SAPs; DSMB SAPs and Charters
Write project level or therapeutic area level documentation




Perform QC of SAP text and develop standard SAP text and templates to be used within the company
SAP/shell creation and review

Qualifications

Educated to PhD or MSc in Biostatistics/Statistics or a closely related field
Extensive CDISC experience (SDTMs and ADaMs)
Proficient in SAS, R experience is advantageous
Previous experience working as a Lead Statistician
Previous experience with SAP/shell creation and review
Previous experience working with a Programming team – reviewing dataset specifications and outputs
Ability to work independently and collaboratively in a fast-paced environment

Why Join Us

Remote working and flexible working hours
Career development, mentorship, and continuous learning
Supportive, friendly, and collaborative culture

About Phastar

Phastar is an award-winning biometrics and data science CRO, trusted by pharma, biotech, and medical device companies worldwide. With a general team of data specialists, we bring expertise, precision,

📌 Principal Statistician (España)
🏢 PHASTAR
📍 España