Senior Biostatistics Manager — Clinical Design & Analysis

Alexion Pharmaceuticals, Inc.; Boston (MA); On-site; USD 120,000 - 157,000; Full time

Benefits offered by this job

Retirement benefits

Paid time off

Health, dental, and vision coverage

Job summary

Alexion Pharmaceuticals, Inc. in Boston, MA seeks a Senior Manager, Biostatistics to lead independent statistical activities across clinical trial design, delivery and interpretation, and regulatory submissions.

This role coaches staff, develops creative statistical approaches, and collaborates across functions to improve study quality and efficiency. Requirements include MSc/PhD in statistics or math with a substantial statistical component, 1–2 years in pharma, SAS and R proficiency, and

Qualifications

• MSc/PhD in Statistics or Mathematics with a strong statistical component required.
• 1-2 years of experience in pharmaceutical industry.
• Competent statistical programmer (SAS and R).
• Knowledge of key technical and regulatory requirements.
• Experience in design, analysis and reporting of preclinical or clinical studies in multiple settings.
• Excellent communication and collaboration skills.

Responsibilities

• Provide statistical expertise for complex design and interpretation for preclinical or clinical programs and regulatory submissions.
• Analyze internal and external information, perform modelling to inform design decisions.
• Develop a Statistical Analysis Plan for complex studies.
• Coach less experienced statisticians in analyses, graphics, and study reports.
• Analyze, interpret, summarize and communicate results of complex studies.
• Contribute to regulatory submissions including overview documents and responses.
• Identify opportunities to apply modelling and simulation to improve design.
• Identify opportunities to improve methodology and deliver practical solutions.
• Contribute to development of best practices to improve quality and efficiency.
• Ensure quality of statistical work and pursue coaching or training as needed.

Skills

SAS

R programming

Statistical analysis

Communication skills

Collaboration

Education

MSc/PhD in Statistics or Mathematics containing a substantial statistical component

PhD in Statistics/Biostatistics preferred

Job description

Alexion Pharmaceuticals, Inc. in Boston, MA seeks a Senior Manager, Biostatistics to lead independent statistical activities across clinical trial design, delivery and interpretation, and regulatory submissions.

This role coaches staff, develops creative statistical approaches, and collaborates across functions to improve study quality and efficiency. Requirements include MSc/PhD in statistics or math with a substantial statistical component, 1–2 years in pharma, SAS and R proficiency, and