Our client is a scientifically-driven leader in the development of Oncology and Immunology therapies whose growing pipeline spans a variety of therapeutic approaches. They are currently seeking project-level Statisticians who, by providing statistical support, will be key contributors to drug development programs across a range of phases. Ideally this role will come in at the Senior or Principal level, but can be flexible based on experience. 

In this role you will:

• Interact with members of the multidisciplinary project teams to establish project timelines.
• Provide statistical input to study protocols.
• Write statistical analysis plans.
• Monitor internal and CRO project activities including timelines, deliverables and availability of resources.
• Provide guidance and supervision to 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 pre-IND and NDA activities.
• Participate in the development and enforcement of SOPs and guidelines.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Ph.D. degree in statistics required.
• 2-5 years of experience in pharmaceutical/biotechnology industries and a broad knowledge of biostatistics.
• Group Sequential Design experience 
• Demonstrate ability to work independently in project management and decision making.
• Able to effectively communicate 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.