Associate Director Biostatistics
A multinational pharmaceutical company is looking for an Associate Director of Biostatistics to join their dynamic team in Switzerland. The AD would be responsible for providing statistical support to drug development programs, this is an excellent place to develop your statistical career.
- Serve as a member of the biometrics management team, to manage and support drug development
- Provide strategic input to drug development and the development of the biometrics department.
- Manage and develop statisticians.
- Interact with members of the multidisciplinary project teams to establish project timelines.
- Provide statistical input to study protocols.
- Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
- Provide guidance and supervision to statisticians and programmers in authoring of analysis dataset specifications and programming of tables, listings and figures.
- Interpret study results and provide review of statistical summary reports of study results for accuracy.
- Assist in writing relevant sections of the clinical study report.
- Participate and contribute to authoring of Clinical Development Plan.
- Participate in regulatory activities such as health authority meetings and submission related activities.
- Participate in the development and enforcement of SOPs and guidelines.
Skills and Requirements
- Ph.D. degree in statistics with 7-9 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics, FDA/EMEA guidelines, and the drug development process.
- Experience in oncology drug development, from Phase I to Phase III. Demonstrated ability to work independently in project management and decision making.
- Able to effectively communicate his/her ideas and to manage programmers in a constructive manner.
- Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
- Previous experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
- Knowledge of multivariate analyses and Biomarker analyses is a plus.
In case you have difficulty in applying or if you have any questions, please contact Heidi Hennigan on 44 2038541033 or upload your CV on our website - www.proclinical.com/send-cv
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies