Expert level Biostatistical Consultant
Location: UK, Home Counties
Salary: £ Salary competitive + benefits
Duration: Permanent and full-time
Are you looking for an exciting opportunity and have a passion for work within biostatistics? As an excellent opportunity has arisen with a global Pharmaceutical company based in the UK
Responsibilities:
•Provide statistical support in designing Clinical development programs, individual protocols and preparing submissions
•Design, analyse, interpret and communicate the result studies
•Provide guidance throughout the Clinical development process
•Keep up to date with FDA, EMEA, CPMP, ICH guidelines
•Support interventional and non-interventional studies
•Develop and implement a plan for strategic initiatives
•Attend client meetings
•Business development
•Maintain and monitor budgets
•Resource planning
•Resolve client problems when and as they arise
•Provide internal technical support to the biostatistics department
•Develop agendas and chair department meetings
•Lead the development of new SOPs and guidelines as needed
Qualifications/experience required:
•Have a Ph.D. in Biostatistics or a MSc
•A minimum of 12 years experience in the pharmaceutical industry
•Thorough understanding of the drug/device/ diagnostic development process
•Proven experience in optimizing trial design and development programs
•Experience in different therapeutic areas
•Experienced with submissions
•Understanding of Regulatory guidance
•Experience in a Project Leadership role
•Thorough understanding of e-submissions and ICH guidelines
•Financial knowledge
•Excellent analytical skills
•Fluent English
If you are interested please contact:
Kim Ugodulunwa on +44 (0) 0207 822 1710 or [log in to unmask]
If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place. Please note due to the high level of applications if you are not contacted within 48 hours, you have not been successful on this occasion.
Key Words:
Biostatistics, Director, Business development, Protocols, Submissions, Statistical, FDA, EMEA, CPMP, ICH, PMDA, SFDA, Regulatory, SOP’s, Drug, Device, Diagnostic, Therapeutic areas, Project leader, e-submissions, Ph.D., MSc, Pharmaceutical,
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