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Principal Statistical Programmer - Submissions Group

Employer
PHASTAR
Location
United States (Remote or Hybrid)
Salary
Competitive
Start date
6 Dec 2022
Closing date
20 Dec 2022
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Job Details

ABOUT PHASTAR

PHASTAR is a multiple award-winning global biometrics Contract Research Organization (CRO). 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. Operating across the UK, US, Canada, France, Spain, Germany, Kenya, Australia, India, China, and Japan, PHASTAR is the second largest specialized biometrics provider globally, and the largest in the UK. 

THE ROLE

Demand for our Functional Service Provision is growing, and we are looking for a principal statistical programmer with extensive submissions experience to join our FSP team.

As a principal programmer, you will be fully integrated into our sponsor’s submissions excellence team as a key contributor, providing hands-on technical eSUB expertise including guidance, define, reviewer’s guide, M5/M2 creation and business rules, for submission of clinical trial data for FDA, PMDA and EMA regulatory agencies.

This is a fantastic opportunity to work for a growing CRO that is recognized for its continuous learning and development opportunities, whilst also gaining direct experience of working within our sponsor’s pharmaceutical environment. 

SKILLS AND EXPERIENCE REQUIRED

•    BSc, MSc or PhD in mathematics, science, or IT related discipline
•    Substantial experience working as a SAS statistical programmer
•    Extensive experience in CDISC formatted regulatory submissions
•    Ability to keep up to date with guidance from regulatory authorities
•    Hands-on experience in eSUB requirements for various regulatory agencies
•    Analytical mindset and proven experience in short and long-term strategy planning for submission
•    Ability to work independently within minimum oversight
•    Excellent written and verbal communication skills

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, 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!

APPLY NOW

With the world’s eyes focused on clinical trial data, this is a fantastic time to join an award-winning specialized biometrics CRO that is renowned for its technical expertise, outstanding quality, and cutting-edge data science techniques. 

*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.

 

Company

PHASTAR is a specialist biometrics contract research organization offering statistical consulting, clinical trial reporting, data management and data science services by providing expert consultants and managing and delivering in-house projects, FSP-style arrangements and preferred partnerships. Our number one priority is ensuring on time, quality work: every project undertaken is supervised on methodology and utilizes internal processes designed to guarantee optimal quality, inspired by 4,000 years accumulated technical experience across the company. PHASTAR is headquartered in London (UK) and North Carolina (US) and has 14 offices worldwide

Find Us
Location
Unit 2,
2A Bollo Lane
London
W4 5LE
GB
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