Senior Manager, Biostatistics - Genetics Medicine

Role Summary

Senior Manager, Biostatistics - Genetics Medicine at Regeneron. Support Clinical Biostatistics within Global Development, collaborating with cross-functional teams to frame statistical approaches, design studies, analyze data, and interpret results to inform decision making. Lead mentoring of junior statisticians and contribute to training, infrastructure development, and external engagement.

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 methodologies for data analysis.
• Collaborate with Statistical Programming on the programming of tables, figures, and listings to support decision making and regulatory reporting.
• Evaluate the suitability of software for planned analyses and identify needs for novel statistical methods or tools.
• Analyze data and interpret results from clinical trials and non-trial data to facilitate program-level decision making.
• Prepare presentations and written reports to communicate results to project teams, management, and regulatory agencies; co-present findings to management.
• Engage in research activities for innovative statistical methods and applications and provide training to non-statisticians.

Qualifications

• Required: PhD or equivalent in statistics/biostatistics with >4 years’ experience in the pharmaceutical industry, or MS in statistics/biostatistics with >9 years’ experience.
• Required: Knowledge of drug discovery and development and ability to integrate statistical concepts into development strategies.
• Required: Excellent influence and leadership skills and ability to collaborate in a cross-functional environment.
• Required: Ability to work productively in a fast-paced, collaborative environment with strong critical thinking, time management, and communication skills.
• Required: Solid knowledge of statistical analysis methodologies, experimental and clinical trial design.
• Required: Expertise in statistical software such as R or SAS.

Skills

• Cross-functional collaboration
• Statistical programming and analysis
• Regulatory reporting support
• Communication of complex statistical results to diverse audiences

Education

• PhD or equivalent degree in statistics/biostatistics, or MS with substantial industry experience as listed above.