Biostatistician - Iii

Contractor, Biostatistics The Contractor, Biostatistics will be responsible for all statistical aspects within a clinical development program, including statistical input into the clinical development plan, support of clinical research, design and analysis of clinical trials, interaction with other functions and outsourcing partners. The Contractor, Biostatistics will be accountable for the validity and quality of all statistical input and deliverables for the assigned projects. Additionally, this contractor biostatistician will provide consultancy to other project teams within research and development, regulatory affairs, manufacturing, and quality.
Responsibilities (include but are not limited to):
Provides statistical expertise and input to drug development programs including the design of clinical development plans, studies, and analyses requiring advanced statistical methodologies. Recognizes and addresses issues which may affect the statistical integrity of the development program or for which statistical tools may add value. Provides statistical input into the preparation of marketing applications (NDA/BLA) to FDA, EMEA or other worldwide regulatory agencies. Develops and reviews statistical analysis plans, including the definitions of derived variables, the structure and content of analysis datasets, statistical analyses, and the design of templates for statistical tables, figures, and listings for clinical study reports. Supports technical reports and publications, ensures the timely delivery of statistical study results. Ability and experience to guide data management and programming in developing standards for building databases, edit checks, and statistical programming for data analyses. Works collaboratively with Statistical Programmers, Biostatisticians, Clinical Research Associates, Clinical Data Managers and other Clinical, Global Drug Safety, Regulatory, Project Management staff and vendors to meet project deliverables and timelines. Knowledge of advanced clinical trial design concepts and an understanding of clinical / regulatory concepts in oncology. Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
Requirements:
PhD in biostatistics, statistics, mathematics, or equivalent = 4 years of industry working experience in biostatistics in clinical development and drug development experience Can pull together highly effective teams and create a clear sense of direction. Advanced and broad knowledge of statistical methods, along with understanding of industry practices related to drug development Excellent verbal, written, and presentation skills including the ability to clearly describe advanced statistical techniques and interpret results Working knowledge of R, and/or SAS