Senior Manager, Biostatistics - Thrombosis

Role Summary

A qualified statistician/biostatistician supporting Clinical Biostatistics within Global Development. You will work with cross-functional teams to articulate drug development questions, assess endpoint feasibility, and frame statistical approaches; design clinical experiments and interventional studies to generate and analyze data; and help interpret results to inform decisions. You will participate in regulatory agency meetings, co-author clinical study protocols and statistical analysis plans, and perform analyses for interim and final reports. You will also develop and deliver training, lead infrastructure and process improvements, and contribute to external scientific dialogue through professional activities. As a Senior Manager, you will mentor and oversee less-experienced statisticians and may manage contract staff.

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 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 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 and provides training to non-statisticians.

Qualifications

• PhD or equivalent degree in statistics/biostatistics with >4 years of experience in the pharmaceutical industry, or MS degree in statistics/biostatistics with >9 years of 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.

Skills

• Leadership and cross-functional collaboration
• Strong communication and presentation skills
• Critical thinking, time management, and ability to work in a fast-paced environment
• Proficiency in statistical software (R, SAS)
• Knowledge of statistical analysis methodologies and clinical trial design
• Ability to train and mentor non-statisticians