The company
A leading full-service clinical research organisation which offers high-quality solutions to pharmaceutical, biotechnology and medical device companies around the globe.
The role
Provide expert consultation and provide statistical advice and strategic leadership from plan to execution during all Phases of drug development. Provide direction to statisticians on statistical and programming principles and methodology. Perform supervisory and management functions relating to the administrative and scientific activities of statisticians. Develop and direct appropriate and innovative study design, analysis and reporting of clinical study results. As a formal member of a cross-functional clinical drug development team, plan and implement clinical drug development programs.
Responsibilities
- Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies.
- Responsible for an area of significant corporate impact and line management for a group of highly trained professionals.
- Provide strategic and statistical leadership; lead the statistical group to complete projects in a timely and quality manner.
- Represent statistical group and give expert consultation and advice in project planning and corporate level meetings; identify mission critical needs of the departments.
- Supervise the activities of statisticians, be proactive in resolving issues and establishing team performance standards to ensure that the team functions with the highest efficiency. Establish effective relationships with clients.
- Establish and ensure the use of standards for analysis and reporting of clinical study data.
- Contribute to the implementation and execution of the drug development plan, assist in the determination of strategic objectives for regulatory filing.
- Independently develop statistical methodology appropriate for the analysis of clinical studies utilizing knowledge of regulatory guidelines and statistical methodology.
- Participate in conducting statistical research and developing design, analysis and innovative statistical methodologies to improve the drug development process.
Experience
- MS or PhD in Statistics, Biostatistics or related field. PhD with 6+ years related experience or MS with 8+ years of experience.
- Strong oral and written communication skills, with ability to communicate effectively throughout all levels of the organization.
- Demonstrated capability to set clear priorities and effectively manage multiple projects.
- Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations.
- Demonstrated ability to identify areas of statistical research in improving the design, analysis and reporting of clinical study.
- Demonstrated pharmaceutical or related industry experience with clinical trials and interaction with Regulatory Agencies, especially FDA
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything.