Principal Biostatistician – FSP

Job not on LinkedIn

🔥 1 minute ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🔴 Lead

🧪 Clinical Research

👻 Ghost score 25%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Clinical Outcomes Solutions

WebsiteLinkedInAll Job Openings

51 - 200 employees

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

Clinical Outcomes Solutions is a global clinical outcomes consultancy that provides comprehensive support and services in all aspects of Clinical Outcome Assessment (COA) research. The company helps inform patient care by capturing the patient voice through innovative scientific methods. It guides organizations in navigating the complexities of clinical outcomes research by crafting strategies and solutions to capture accurate data. Trusted by pharmaceutical and biotechnology companies, the firm ensures regulatory compliance and optimized patient outcomes.

📋 Description

• Support Phase I-IV clinical studies • Perform ad-hoc or exploratory analyses to support submissions or Health Authority Questions • Provide statistical support to clinical studies • Participate in study protocol development, study design discussions, and sample size calculations • Review CRFs and data review guidelines • Develop statistical analysis plans (SAPs), including analysis dataset and TLG specifications • Perform statistical analyses and interpret statistical results • Prepare clinical study reports, including integrated summaries for submissions • Present and explain methodology and the consequences of decisions • Work fully embedded within and dedicated to a global pharmaceutical client while supported by Cytel • Collaborate with clinical, regulatory, programming, internal, and external teams

🎯 Requirements

• Master’s degree in statistics or a related discipline • 3+ years supporting clinical trials in the Pharmaceutical or Biotechnology industry • Experience working for a CRO is strongly desired • Experience in sample size calculation, protocol concept development, protocol development, SAP, and preparing clinical study reports including integrated summaries for submissions • Good SAS programming skills for QCing critical outputs, Efficacy/Safety tables, and working closely with Programmers • Solid understanding and implementation of CDISC requirements for regulatory submissions • Adept in ADaM specifications generation and QC of datasets • Ability to build strong external and internal relationships and motivate a regional or global team • Effective communication skills; able to explain methodology and consequences of decisions in lay terms • Knowledge of R programming is a plus • Regulatory work experience is a bonus

🏖️ Benefits

• Consistent training, development and support • Significant professional growth • Professional development opportunities