Associate Director / Director Biostatistics
Laura Christie at CK Clinical is recruiting for an Associate Director / Director Biostatisitcs to join a Global Pharmaceutical company based in London, working on a full time, permanent basis.
Main duties and responsibilities:
- Provide statistical leadership in the design, analysis, and interpretation of clinical studies at a compound level and/or therapeutic area (TA) level, promoting innovative design and analysis methodology.
- Providing strategic statistical input for feasibility assessments, development plans, cross-study analyses and regulatory submissions and interactions.
- Independently representing Statistics function in interactions with regulatory authorities and statistical working groups.
- Monitoring and implementing advances in statistical and clinical trial methodology for assigned programs, and promoting use of innovative methodologies.
- PhD/MSc in biostatistics or equivalent with extensive industry experience
- Expert knowledge of statistical design/analysis methodology including latest developments and reporting procedures utilized in support of clinical trials.
- Active in statistical/pharmaceutical professional organisations at regional or national level.
- Advanced knowledge of the pharmaceutical industry including understanding of clinical drug development process and documents.
- Advanced knowledge of FDA and ICH regulations and industry standards applicable to the design and analysis of clinical trials.
- Experience consulting and/or independently representing Statistics function in interactions with regulatory agencies, eg, end of Phase II, pre-submission meetings or advisory committee meetings with complex and challenging issues.
- Excellent oral and written communications skills.
- General knowledge of multiple statistical software programs, and good knowledge of programming with respect to more complex statistical methods (eg, simulations). A full job spec is available upon request.
If you have the skills and experience for this role, please contact Laura Christie with your updated CV on 07443 111928 or email LChristie@ckclinical.co.uk. Alternatively click on the link below to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34551 in all correspondence.