Senior Biostatistician, Safety Statistics

Company: PHASTAR
Location: Bennett
Posted on: November 16, 2021

Job Description:

THE COMPANY

PHASTAR is a multiple award-winning global biometric Contract Research Organization (CRO) that is accredited as an outstanding company to work for by Best Companies. We partner with pharmaceutical, biotechnology and medical device organizations to provide the expertise and processes to manage and deliver on time, quality biostatistics, programming, data management and data science services. 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.

THE ROLE

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

SKILLS AND EXPERIENCE REQUIRED
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 specialized biometric CRO that is renowned for its technical expertise, outstanding quality and cutting-edge data science techniques. We offer flexible working, part-time hours, structured training and development plans, continuous learning opportunities, and a competitive salary and benefits package. We're committed to ensuring our employees achieve a healthy work-life balance, within a supportive, fun and friendly working environment.

*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.

Keywords: PHASTAR, High Point , Senior Biostatistician, Safety Statistics, Other , Bennett, North Carolina