Senior Director, Biostatistics & Clinical Development

Lantheus; Massachusetts; On-site; USD 206,000 - 381,000; Full time

Benefits offered by this job

Health benefits

401(k) with company contribution

Paid time off

Job summary

Lantheus, a leading radiopharmaceutical company headquartered in Massachusetts, seeks an Executive Director of Biostatistics to lead clinical development statistics for all phases. This role is based in Bedford, MA with on-site presence two to three days per week and requires collaboration across Clinical Development, Regulatory, and cross-functional teams.

The candidate will design statistical strategies, author regulatory documents, and ensure high-quality data interpretation for submissions.

Qualifications

• PhD in Biostatistics or a related field.
• Typically, 20+ years in the pharmaceutical industry or CRO with at least 10 years in a management position.
• Prior experience as a lead Biostatistician in clinical development.
• Prior experience managing clinical teams to design and implement studies.
• Experience in writing statistical sections of protocols and CSRs.
• Experience with CRFs and programming specifications.
• Excellent communication skills and technical writing experience.

Responsibilities

• Provide expert statistical consultation to Lantheus management across Clinical Development and Asset Teams.
• Lead the Biostatistics team and direct and execute statistical strategy for development programs.
• Evaluate and manage CROs and vendors, overseeing scope, timelines, and study activities.
• Lead the process and review of in-house and external programming deliverables.
• Stay current with advancements in statistical methodology and apply them to meet evolving needs.
• Contribute to protocol development, study design, sample size, and statistical methods.
• Contribute to study activities, CRF development, database design, and data cleaning.
• Write/review Statistical Analysis Plans for studies and regulatory submissions.
• Work with leadership to develop department policies, standards, and procedures.
• Ensure final deliverables meet CDISC standards for regulatory submissions.

Education

PhD in Biostatistics

Tools

SAS software

Job description

Lantheus, a leading radiopharmaceutical company headquartered in Massachusetts, seeks an Executive Director of Biostatistics to lead clinical development statistics for all phases. This role is based in Bedford, MA with on-site presence two to three days per week and requires collaboration across Clinical Development, Regulatory, and cross-functional teams.

The candidate will design statistical strategies, author regulatory documents, and ensure high-quality data interpretation for submissions.