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Director, Biostatistics (US - Remote or Hybrid)

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

View more

Discipline
Data Management / Statistics, Biostatistics, Statistics
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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. 

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 honor, 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 director of biostatistics, you will provide support to the global head of statistics and members of the statistics function. You will line manage more experienced statisticians within the organization, providing support in issue escalations, and pastoral care including careful guidance, leadership, training, and mentoring. You will provide senior review and oversight of documentation and deliverables, and ensure they are delivered to optimal quality, on time, and within budget. You will support the head of statistics to ensure the statistics function has the appropriate personnel and skills to complete jobs effectively and will support operational success of studies through careful planning and work assignments. You will provide input to quality processes through creation and review of SOPs, tracking of quality performance metrics, involvement in CAPA processes, and ensuring implementation of quality processes.

As a member of the management team, you will represent the statistics function at management meetings and help to drive continuous improvement within the function and through collaboration with other functions. You will also support business development and recruitment activities.

Key Responsibilities:
•    Assist the head of statistics in providing timely communication to the function
•    Leadership of members of the statistical function within specific geographical regions
•    Line manage senior members of staff within the statistics function, allowing individuals the opportunity to reach their full potential
•    Train and mentor line managers and less experienced members of staff within the statistics function
•    Support resolution of any issues escalated by, or involving, statistics team members
•    Support the operational success of studies through careful planning and work assignments
•    Help the head of statistics to identify areas of skill development for the statistics function as a whole
•    Work closely with cross-functional operational leadership team
•    Communicate with management and senior leadership on progress, and prepare reports and presentations as needed
•    Work with QA department to ensure risk management strategies are in place
•    Ensure statistics SOPs are current and reflect the statistics processes
•    Ensure members of the statistics function implement and adhere to best practices and the PHASTAR Discipline
•    Identify areas that new statistical processes are required
•    Work with the Operational Excellence function to implement new processes developed within that function and ensure adherence to the new processes on an ongoing basis
•    Motivate and inspire others
•    Work with the VP Statistical Research and Consultancy, and Director, Statistical Consultancy to identify individuals who can support projects/ideas for furthering statistical research
•    Recruit, interview, hire and train new employees
•    Provide statistical leadership of assigned studies
•    Provide and maintain a positive and engaging client relationship with regards to statistical issues
•    Prepare and review study documentation including protocols and statistical analysis plans
•    Manipulate, summarize, and analyze clinical trial data using a variety of statistical methods
•    Function as statistical lead and/or project lead across multiple studies
•    Complete statistical activities on assigned studies as required
•    Report any potential new business opportunities to the business development manager
•    Maintain visibility to external customers (e.g. white papers, blogs, LinkedIn posts etc.)

SKILLS AND EXPERIENCE REQUIRED
•    Educated to PhD or MSc in biostatistics/statistics or a related discipline
•    Experience within the pharmaceutical/CRO industry to have a good awareness of clinical trial issues, design, and implementation.
•    Familiarity with GCP and regulatory requirements
•    Experience of writing SAPs, protocols & regulatory submissions
•    Experience of working with CDISC data standards and performing statistical analysis using SAS
•    Experience using various statistical modelling techniques
•    Project leadership experience
•    Line management experience
•    Ability to communicate with a broad range of people across different functions
•    Excellent written and verbal English
•    Implement approaches that will result in error-free results
•    Good knowledge of SAS procedures required for conducting statistical analyses
•    Proactive in identifying and resolving statistical issues throughout study conduct and feedback to relevant team members

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. 

*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

Company info
Location
Unit 2,
2A Bollo Lane
London
W4 5LE
GB

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