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Director, Biostatistics (Ref: RM)

Employer
PHASTAR
Location
United States - Remote
Salary
Competitive
Start date
30 Sep 2022
Closing date
25 Oct 2022

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Job Details

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

 

The role of Director, Biostatistics provides support to the Global Head of Statistics and members of the statistics function. The role includes line management of more experienced statisticians within the organisation, support in issue escalations, and pastoral care including careful guidance, leadership, training and mentoring. They will provide senior review and oversight of documentation and deliverables, ensuring they are delivered to optimal quality, on time and within budget.  They will support the Head of Statistics to ensure the statistics function has the appropriate personnel and skills to complete their jobs effectively. They will support operational success of studies through careful planning and work assignments. They 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.

 

They will represent the statistics function at management meetings, and help to drive continuous improvement within the function and through collaboration with other functions. They will support business development and recruitment activities.

 

Key Responsibilities:

  • To 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
  • Training and mentoring 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
  • Helping the Head of Statistics 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, prepare reports and presentations, as needed
  • Work with QA department to ensure risk management strategies in place
  • Ensure Statistics SOPs are current and reflect the Statistics processes
  • Involvement in the CAPA process
  • Ensure members of the statistics function implement and adhere to best practices and the PHASTAR checklist
  • Support the tracking of performance metrics related to quality of statistics deliverables Identify areas that new statistical processes are required
  • Work with Operational Excellence function to implement new processes developed within that function and ensure adherence to the new processes on an ongoing basis
  • Monitor ongoing statistics function performance and look for improvements
  • Motivate and inspire others
  • Provide solutions/advice to issues/questions raised by team members
  • 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, as needed Identifying strategies to increase retention rate
  • 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, summarise and analyse 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
  • Liaise with reporting teams and answer questions
  • Report any potential new business opportunities to the business development manager
  • Maintain visibility to external customers (e.g. white papers, blogs, LinkedIn posts etc)

 

Essential Skills and Experience Required:

  • Educated to PhD or MSc in Biostatistics/Statistics or a related discipline
  • Experience within the pharmaceutical 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 CRO or pharmaceutical background
  • 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 Excellent teamwork, willingness to help others, ability to problem solve and seeing others point of view
  • Enthusiastic and positive outlook
  • Calm and professional under all circumstances
  • Implement approaches that will result in error-free results
  • Flexible and adaptable in outlook
  • Open to feedback with a view of continual improvement
  • Good SAS programming skills or knowledge of other statistical packages such as R or STATA
  • Good knowledge of SAS procedures required for conducting statistical analyses Ability to work competently and independently in a cross-functional environment
  • 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. 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.***

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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