Expert Statistician
6 month rolling Contract
Based in UK or Switzerland
Summary:
The Expert Statistician is fully responsible for scientific input into projects and studies in both early and late phases of development (Profiling and PK studies). The expert statistician is fully responsible for the operational aspects of the project, and for effective interactions with the project teams.
Role / Responsibilities:
1. Provide operational oversight for all CIS deliverables for assigned projects and studies, including full responsibility for timelines and quality standards. Scope of projects may include those in very early phases of development leading up to a proof of concept (PoC), but also the ED aspects of late phase projects and submissions.
2. Provide scientific input and advise to project and study teams, and provide guidance and leadership with respect to innovative approaches to study design and decision making; ensure appropriate involvements of M&S, Statistical Methodology and other internal or external statistical consultants in all assigned projects.
3. Contribute to Clinical Development Plans for assigned projects.
4. Partner with the project and study teams, and represent Biostatistics in review and decision boards such as protocol review committee and PoC peer review.
5. Be accountable to the TA lead statistician in the Respiratory TA and to the global head of ED Biostatistics for timeliness and high quality of all CIS deliverables in assigned projects.
6. Interact with Health Authorities and external consultants and experts as appropriate.
7. Support evaluation of in-licensing opportunities as appropriate.
8. Provide technical statistical leadership within the ED Biostatistics group, and may serve as mentor to more junior members of staff.
Essential Skills:
Educated to PhD level in statistics or equivalent degree / knowledge / expertise, you will be experienced in all main tasks of a Senior Statistician and experience as project statistician for international clinical teams or comparable experience in similar ED role. You will also have;
1. Good leadership skills.
2. Very good project management skills.
3. Very good communication and presentation skills
4. Good knowledge of the drug development process and relevant HA guidelines.
5. Basic coaching and mentoring skills.
6. Good team player.
7. Strong knowledge and expertise in statistics and its applications in clinical trials.
8. Experience with implementation of novel methods and/or innovative strategies.
9. Fluent in English
Regards
James Carrera
Manager - Pharmaceutical, Healthcare & CRO Division
Tel: +44 (0) 207 255 6665 [log in to unmask]
Fax: +44 (0) 207 255 6656
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