Principal Biostatistician/Associate Director, Safety Statistics - Remote (Ref: RM)

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Posted 7 days ago United States Salary undisclosed
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Job Description

THE COMPANY

PHASTAR is a multiple award-winning, data focused CRO specializing in providing statistics, programming, data management and data science services. With offices across the UK, US, Germany, Kenya, Australia, India 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.

THE ROLE

As a Principal Biostatistician/Associate Director, Safety Statistics, you will hold a project leadership and high-level statistical consultancy role. Working closely with the pharmacovigilance (PV) team, you will utilise your safety statistics expertise to understand the requirements and articulate their needs to the biometrics team, ensuring 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 manage assigned studies (tracking of biostatistics activities, timelines and resources)
  • Interact with regulatory agencies and effectively address statistical questions and requests
Skills and Experience Required:
  • PhD or MSc in Biostatistics or related discipline
  • Substantial 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 safety databases used within the pharmaceutical/biotechnology industry
  • Knowledge of FDA, EU, ICH guidelines and regulations
  • Extensive project leadership experience
  • Outstanding communication skills with the ability to collaborate with and manage internal and external stakeholders including CROs and vendors
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.

If you feel you have the right skill set and motivations, we would love to hear from you - so please get in touch!

*PHASTAR does not accept any CVs received from recruitment agencies. In the event that speculative CVs are submitted by recruitment agencies, PHASTAR reserves the right to contact these candidates directly and consider them for current/future vacancies without any financial obligation to the recruitment agency in question. This applies to any CVs sent directly to any PHASTAR employee.