Principal Biostatistician - Genetic Medicine

This position is for a qualified Statistician/Biostatistician to support Clinical Biostatistics within Global Development.

A typical day might include

Working with cross-functional teams to articulate drug development questions, assess the feasibility of endpoints and frame statistical approaches to address those questions, design clinical experiments and interventional studies to generate and analyze the resulting data, and work with teams to appropriately interpret the results and make decisions. Co-authoring clinical study protocols, statistical analysis plans, and performing statistical analyses for interim and final reports. Developing and delivering training to non-statistical colleagues, collaborating on development of new infrastructure and processes, and influencing the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.

Key Responsibilities

• Interact with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials
• Develop individual protocols and statistical analysis plans and determine appropriate statistical methodology for data analysis
• Collaborate with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting
• Evaluate appropriateness of available software for planned analyses and determine needs for use of novel statistical methodology or tools
• Analyze data and interpret results from clinical trials and of data from non-trial sources to facilitate program-level decision making
• Prepare presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies
• Involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians

Requirements

• PhD or equivalent degree in statistics/biostatistics or related disciplines with internship experience, or MS degree in statistics/biostatistics with >5 years' experience in the pharmaceutical industry as a statistician
• Excellent influence and leadership skills, and a demonstrated ability to collaborate in a cross-functional environment
• Must be able to work productively in a fast-paced collaborative environment, with demonstrated critical thinking skills, time management skills, and effective communication skills
• Solid knowledge of statistical analysis methodologies, experimental and clinical trial design
• Expertise in statistical software such as R or SAS is required