Manager, Biostatistics

Role Summary

This position is for a qualified statistician/biostatistician to support Clinical Biostatistics within Global Development. The incumbent will work 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. The incumbent will co-author clinical study protocols, statistical analysis plans, and perform statistical analyses for interim and final reports. The incumbent will also develop and deliver training to non-statistical colleagues, collaborate on the development of new infrastructure and processes, and influence the external pharmaceutical industry and regulatory environment through participation in professional associations, conferences, and publications.

Responsibilities

• Interacts with Medical Directors, Clinical Scientists, Regulatory Affairs, Preclinical scientists, Statistical Programming, Data Management, Medical Writing, and others to design and analyze clinical trials.
• Develops individual protocols and statistical analysis plans and determines appropriate statistical methodology for data analysis.
• Collaborates with Statistical Programming on the programming of tables, figures and listings to support decision making and for regulatory reporting.
• Evaluates appropriateness of available software for planned analyses and determines needs for use of novel statistical methodology or tools.
• Analyzes data and interprets results from clinical trials and of data from non-trial sources to facilitate program-level decision making.
• Prepares presentations and written reports to effectively communicate results to the project team, management, and regulatory agencies. Co-presents findings to management.
• Is involved in research activities for innovative statistical methods and applications in clinical trial development as well as providing training to non-statisticians.

Qualifications

• PhD or equivalent degree in statistics/biostatistics with >2 years‚Äô experience in the pharmaceutical industry
• MS degree in statistics/biostatistics with >7 years‚Äô experience

Experience

• Knowledge of drug discovery and development and ability to integrate statistical concepts into drug discovery and development strategies.
• 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.