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THE COMPANY

PHASTAR is a multiple award-winning, data focused CRO specializing in providing statistics, programming, data management and data science. With offices across the UK, US, Germany, Kenya, Australia, India, China and Japan, PHASTAR is the second largest specialized biometrics provider globally, and the largest in the UK.

Our unique approach to data analysis, “The PHASTAR Discipline”, has led us to build a reputation for outstanding quality. With this as our core focus, we’re looking for talented individuals who share our passion for quality and technical expertise to join our team.

 

 

Senior Biostatistician, Safety Statistics

in US - remote
Permanent
Start date: As soon as possible
Role and responsibilities

As a senior biostatistician, safety statistics, you will hold a hands-on, operational role. The successful candidate will have a keen interest in safety statistics, ideally with prior knowledge of reporting safety data, but training can be provided if you have not worked in this area before. Working in collaboration with the pharmacovigilance (PV) team, you will help to ensure the timely delivery of high-quality safety statistical analyses across a range of development programs.

Key Responsibilities:

  • Utilize advanced statistical methodologies for assembling, analyzing and reporting safety data on multiple products to deliver high quality timely results
  • Use cutting-edge methods such as machine learning to analyze big data sets for effective signal detection and reporting
  • Support the development of safety statistical analysis sections of clinical development plans, protocols, SAPs, and specifications for statistical programming implementation of safety statistical analyses
  • Collaborate with internal and external stakeholders to ensure effective quantitative approaches are applied to the collection and analysis of a wide variety of data types
  • Project leadership of assigned studies (tracking of biostatistics activities, timelines and resources)
  • Interact with regulatory agencies and effectively address statistical questions and requests
Experience
  • PhD or MSc in biostatistics or related discipline
  • Knowledge of reporting safety data (i.e. SUSARs, AEs) preferred but not essential
  • Knowledge of safety databases used within the pharmaceutical/biotechnology industry
  • Experience working within a clinical trials environment (CRO, biotech, pharma or regulatory agency) to have a good awareness of clinical trial issues, design and implementation
  • Excellent statistical knowledge with the ability to solve scientific and clinical problems
  • Knowledge of FDA, EU, ICH guidelines and regulations
  • Project leadership experience
  • Excellent communication skills with the ability to collaborate with internal and external stakeholders including CROs and vendors
  • Demonstrate a keen interest and enthusiasm for safety statistics

WHY PHASTAR

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialist biometrics CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer structured training and development plans, the opportunity to continue your own research, flexible working arrangements, a competitive salary and an industry-leading benefits package, all within a relaxed, fun and friendly working environment.

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