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Senior Consultant

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About the role

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Senior Consultant, Clinical Trials Methodology
This is an exciting opportunity to work within a fast paced, busy environment for a leading global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries.  This person will be leading the development and consulting on innovative statistical trial methodologies
 
 
Overview of the Role
  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • As a Manager, the employee is expected to recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
  • Travel (approximately 30%) domestic and/or international.
  • Provide methodological expertise in the area of adaptive clinical trials and strategic direction as a drug development consultant to internal teams, including project feasibility, protocol review and evaluation, in collaboration with relevant departments.
  • Participate in statistical consultancy for proposals teams and operational teams
  • Provide statistical leadership in the innovative trial design area for the proposal writing process and the bid defense process
  • Participate in project review, scientific oversight, and support for operational teams in the execution of active projects in the adaptive design area.
  • Provide expert advice into new services and growth in drug development in the specified innovative design area.
  • Contribute to the marketing and selling of ICON’s Drug Development Consulting Services to external clients.
  • Provide statistical leadership for pre-selling and marketing activities in the innovative design area, including the creation of material for web-publishing, organizing webinars, client meetings, and academic publications.
  • Provide drug development consultancy services to external clients: including the planning and simulation of statistical designs.
  • Work collaboratively with colleagues in other departments, including Project Management, Data Management, Regulatory Affairs, and Biostatistics to develop and review clinical development plans, and individual study protocols for external clients.
  • Develop and maintain relationships with key opinion leaders, advisory boards, and regulatory bodies.
  • Maintain statistical expertise, including attendance at professional and academic conferences.
  • Promote ICON’s interests in a leadership role by working strategically, operationally and within a business development capacity.
  • Undertake other relevant duties as may be assigned by the senior leadership.
  • Support and actively participate in the ADDPLAN software development.
 
Role Requirements
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Experience in clinical research, gained from academia and/or the drug development industry.  Academic record to include high quality publications as first or last author, industry background to include appointments in either CRO or pharmaceutical companies with experience in drug development strategy.
  • Knowledge of regulatory affairs, preferably with experience of interaction with US and/or EU regulatory authorities.
  • Fluency in English, both orally and in writing, with excellent communication skills.
  • Master’s degree in Statistics or Mathematics, or equivalent.  One or more higher research degree (e.g. MSc, DM, PhD, DSc) is preferred.
Benefits of Working in ICON
 
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package.  This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
 
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.   
 
What’s Next?
 
Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.
 
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
 
 
ICON is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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