Associate Director of Statistics

Hobson Prior are looking for an Associate Director of Statistics to join a world-wide biopharmaceutical organisation who specialize in oncology product development and pioneering medicines that are used all over the world. The primary responsibility of this position is to provide statistical support to drug development programs.

Job Responsibilities:

• Accountable to serve as a member of the biometrics management team, to manage and support drug development in the organisation.
• You will provide strategic input to drug development and the development of the biometrics department.
• Interact with members of the multidisciplinary project teams to establish project timelines.
• Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
• Manage and develop statisticians.
• Provide statistical input to study protocols.
• Write and review statistical analysis plans.
• 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.
• Partake and contribute to authoring of Clinical Development Plan.
• Partake in regulatory activities such as health authority meetings and submission related activities.
• Partake in the development and enforcement of SOPs and guidelines.

Key Skills:

• 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.

Requirements:

• Ph.D. degree in statistics.
• 7-9 years of experience in the 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.
• Ability to use SAS to perform efficacy analyses and validate important data derivations when necessary.
• Prior experience in dealing with Health authorities such as discussions/negotiations in filing strategies are highly desirable.
• Knowledge of multivariate analyses and Biomarker analyses is admirable.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.