Remote FSP Principal Biostatistician - Phase II/III Oncology and Rare Disease (Ref: RM)

Company: PHASTAR
Location: Irvine
Posted on: June 24, 2022

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.
WHY PHASTAR
Accredited as an outstanding company to work for, PHASTAR is committed to employee engagement, workplace satisfaction and ensuring a healthy work-life balance. We offer flexible working, part-time hours, involvement in developing company-wide initiatives, structured training and development plans, and a truly supportive, fun and friendly environment.
What's more, when you join our team, PHASTAR will plant a tree in your honour, as one of our Environmental, Social and Governance (ESG) initiatives. So, not only would you get your dream job, you'll also be helping to save the planet!
THE ROLE
As an FSP Principal Biostatistician, you will hold a combined project leadership and hands-on technical statistics role. You will work directly with one of our key clients, working across a range of phases and therapeutic areas, you will lead assigned studies, ensuring they are delivered to optimal quality, on time and on budget.
Key Responsibilities:

• Lead a team of statisticians and programmers to manipulate, summarize and analyze clinical trial data using a variety of statistical methods
• Project manage assigned studies including allocating staff, predicting and planning resources
• Prepare and review study documentation including protocols and statistical analysis plans
• Advise, mentor and teach internal and external statisticians with regards to statistical and data analysis methods
• Function as a study expert across multiple studies, helping to clarify details on analysis methods for the internal PHASTAR team
• Ensure the team meets the highest quality standards and follows the principles detailed in PHASTAR's internal procedures
• Maintain a positive and engaging client relationship with regards to statistical issues
  Skills and Experience Required:
  • PhD or MSc in Biostatistics or related discipline
  • Experience working within a clinical trials environment (CRO, pharma or academic)
  • Experience supporting regulatory submissions, interacting with the FDA and/or global regulatory authorities
  • Experience working with orphan indications (advantageous, not essential)
  • Previous experience performing statistical analysis using SAS
  • Excellent written and verbal communication skills
  • Ability to communicate with a broad range of people across different functions
    APPLY NOW
    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.
    Should you feel that you have the right skill set and motivations for this position, please apply! Please note that we are considering candidates located anywhere in the US as this role can be carried out remotely.
    ***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, Irvine , Remote FSP Principal Biostatistician - Phase II/III Oncology and Rare Disease (Ref: RM), Healthcare , Irvine, California